Hyperbaric Oxygen Treatment Lymphedema

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Hyperbaric Oxygen Treatment Lymphedema

Postby patoco » Mon Jun 19, 2006 6:14 pm

Hyperbaric Oxygen Treatment Lymphedema

Our Home Page: Lymphedema People

http://www.lymphedemapeople.com

=================

Original Post 05/22/2005

Bends cure could aid cancer women

By Jane Elliott
BB News health reporter

Shirley Fenton had a badly swollen arm
Decompression chambers, used to treat deep-sea divers with the bends, could hold the key to relieving a painful side effect of breast cancer.
Experts believe lymphoedema - severe swelling in the arm following radiotherapy - could be alleviated by breathing in pure oxygen.

A trial funded by Cancer Research UK is now looking for 63 women to test their theory.

Previous trials have already produced promising results.

Five years ago Shirley Fenton, 66, from Buckfastleigh, in Devon, took part in the pilot trial, led by the Royal Marsden Hospital and The Institute of Cancer Research.

Progress

She said: "The swelling in my arm has reduced by 10% and the arm has softened quite a lot.

"Before there was no give in it. Now there is no difference to the other side.

"I had swollen fingers that I used to call my sausage fingers, but now I can get my rings on."

We were breathing pure oxygen

Shirley Fenton

Shirley first had breast cancer when she was a young mother of 34.

She had a lumpectomy and radiotherapy, but her lymph nodes were not removed.

Seventeen years later she had another unrelated breast cancer. Again she had a lumpectomy and radiotherapy, but this time surgeons also removed her lymph nodes.

A few years later she started to suffer from a terrible swelling in her arm.

"I did not know what was happening. My arm started to swell up. But I did not let it stop me doing anything and I would still play golf with this enormous arm."

Because Shirley and her contemporaries were the first wave to have their lymph nodes removed, there were few support systems in place - and cancer experts were not as aware as they are today about the symptoms and side effects.

When she was first diagnosed with lymphoedema she was simply given a sleeve, like a stocking for varicose veins, to reduce her swelling.

Later she was told about massage that could help drain the excess fluid.

But she said that because she had the condition for so long, many regarded her as someone whose condition could merely be maintained rather than improved.

Trial

When she heard about the six-week trial in the hyperbaric unit, which helps treat divers suffering from the bends, she agreed to take part.

"We were breathing pure oxygen.

Patients will get 90 minutes of HBO for six weeks.

"And then after 90 minutes we would start to decompress. It was like being in an aeroplane, because your ears pop.

"It was an experience I would not have missed for anything. I found it very enlightening."

The treatment, called hyperbaric oxygen therapy (HBO), will be available in Hull, Plymouth, Gosport and Leytonstone.

Professor John Yarnold, a consultant at the Royal Marsden Hospital, is leading the trial.

He said he hoped to show that HBO treatment could permanently reduce swelling.

This complication has been assumed to be inevitably progressive and irreversible

Professor John Yarnold

"Patients cured of breast cancer by treatments that include radiotherapy to the armpit may be left with a life-long legacy of arm swelling.

"This is thought to be due to narrowing of lymphatic vessels that drain tissue fluid out of the arm, rather in the same way that veins drain blood.

"Narrowing of these channels is caused by scarring (fibrosis) stimulated by the radiotherapy. A very similar syndrome can develop after surgery to the armpit.

"For many decades, this complication has been assumed to be inevitably progressive and irreversible, but our recent research suggests that the condition might be improved by high-pressure oxygen therapy.

"Our current clinical trial aims to test the findings of an earlier pilot study, which reported worthwhile improvements in a proportion of patients who had had radiotherapy up to 30 years ago."

He added: " If the present trial confirms our earlier findings, this will certainly change the way we think about lymphoedema as well as, hopefully, changing the lives of patients living with this condition.

"As part of the trial, we are keen to investigate possible mechanisms by which high-pressure oxygen might improve lymphoedema.

"One of the ideas we are looking into is that high-pressure oxygen may stimulate the growth of new lymphatic channels as well as lead to a reduction in scar tissues surrounding existing lymphatic channels in the armpit."

Volunteers

Two thirds of volunteers recruited to the trial will receive 90 minutes of HBO therapy, five days a week for six weeks.

They will wear a large transparent dome over their heads that supplies pure oxygen through tubes and during this time they will be able to read or talk normally.

The remaining third of volunteers will receive standard care for lymphoedema including bandaging, exercise and massage.

Professor Robert Souhami, at Cancer Research UK, said: "Current therapies for lymphoedema aim to control the symptoms rather than treating the cause.

"There are encouraging signs that hyperbaric oxygen therapy might be an effective treatment and this trial will provide stronger evidence."

Women wishing to check if they are eligible for the study should contact Mrs Lone Gothard, Research Coordinator on 020 8661 3460 or visit the cancer trials database on Cancer Research UK's patient information website.

THIS IS FROM THE BBC

http://news.bbc.co.uk/1/hi/health/4521389.stm

Super Thanks to Silks for sending this in!!
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Clinical Trial Hyperbaric Oxygen Treatment Arm Lymphedem

Postby patoco » Wed Jun 21, 2006 11:46 pm

Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) April 2006

Sponsored by: Royal Marsden NHS Trust

Information provided by: National Cancer Institute (NCI)

ClinicalTrials.gov Identifier: NCT00077090

http://www.clinicaltrials.gov/ct/show/N ... 90?order=2

Thanks Tania for sending this in!!!!

..............

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http://www.lymphedemapeople.com
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Hyperbaric Oxygen Treatment for Lymphedema - Update

Postby patoco » Thu Jun 22, 2006 12:22 am

Hyperbaric Oxygen Treatment for Lymphedema - Update

Our Home Page: Lymphedema People

http://www.lymphedemapeople.com

================

CIGNA Healthcare Coverage Position Number 53, dated May 15, 2005 on
Hyperbaric Oxygen Therapy.

"Lymphedema: Approximately 10-38% of all women who have
breast-conserving surgery (BCS) or modified radical mastectomy have
postsurgical irradiation to the lymph nodes, and 10% of those women
who have BCS with irradiation to the lymph nodes develop lymphedema.
Hyperbaric oxygen therapy has been proposed as an adjunct treatment to assist in reducing lymphedema. A pilot study of 10 patients was
conducted in 2004 by Teas, et al. Results showed a 38% average
reduction in hand lymphedema; however, the total limb volume did not change significantly from baseline measurements after 20 HBO
treatments, and vascular endothelial growth factor-C (VEGF-C) levels
began to increase. This change may suggest that HBO treatment
stimulates the production of this growth factor. The researchers
concluded that additional studies with a larger population of patients are needed to document the effects of HBO on lymphedema.

Ref: Teas J, Cunningham JE, Cone L, Jansen K, Raghavan SK, Nitcheva DK, et al. Can hyperbaric oxygen therapy reduce breast cancer
treatment-related lymphedema? A pilot study. J Women's Health.
2004;13(9):1008-18.

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Journal of Emerging Medical Technologies

May 23, 2005

Those decompression chambers used for divers with "the bends" are
finding another use. Researchers in the UK are treating lymphedema with high-pressure oxygen. Lymphedema can result when irradiated lymph nodes block the return of lymph from the extremities; patients are left with debilitating swollen arms or legs. The BBC reports on Dr. John Yarnold's new clinical trial:

"Patients cured of breast cancer by treatments that include
radiotherapy to the armpit may be left with a life-long legacy of arm swelling. "This is thought to be due to narrowing of lymphatic vessels that drain tissue fluid out of the arm, rather in the same way that veins drain blood...

"For many decades, this complication has been assumed to be inevitably progressive and irreversible, but our recent research suggests that the condition might be improved by high-pressure oxygen therapy...

"One of the ideas we are looking into is that high-pressure oxygen may stimulate the growth of new lymphatic channels as well as lead to a reduction in scar tissues surrounding existing lymphatic channels in the armpit."

(Abtract from Pub Med)

Non-randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema and tissue fibrosis after radiotherapy for early breast cancer.

Gothard L, Stanton A, MacLaren J, Lawrence D, Hall E, Mortimer P,
Parkin E, Pritchard J, Risdall J, Sawyer R, Woods M, Yarnold J.

Department of Radiotherapy, Royal Marsden NHS Trust, Sutton, Surrey SM2 5PT, UK.

BACKGROUND:

Radiation-induced arm lymphoedema is a common and distressing complication of curative treatment for early breast cancer. Hyperbaric oxygen (HBO(2)) therapy promotes healing in bone rendered ischaemic by radiotherapy, and may help some soft-tissue injuries too, but is untested in arm lymphoedema.

METHODS:

Twenty-one eligible research volunteers with a minimum 30%
increase in arm volume in the years after axillary/supraclavicular
radiotherapy (axillary surgery in 18/21 cases) were treated with
HBO(2). The volunteers breathed 100% oxygen at 2.4 ATA for 100 min in a multiplace hyperbaric chamber on 30 occasions over a period of 6 weeks. The volume of the ipsilateral limb, measured opto-electronically by a perometer and expressed as a percentage of contralateral limb volume, was selected as the primary endpoint. A secondary endpoint was local lymph drainage expressed as fractional removal rate of radioisotopic tracer, measured using lymphoscintigraphy.

RESULTS:

Three out of 19 evaluable patients experienced >20% reduction in arm volume at 12 months. Six out of 13 evaluable patients experienced a >25% improvement in (99)Tc-nanocolloid clearance rate from the ipsilateral forearm measured by quantitative lymphoscintigraphy at 12 months. Overall, there was a statistically significant, but clinically modest, reduction in ipsilateral arm volume at 12 months follow-up compared with baseline (P = 0.005). The mean percentage reduction in arm volume from baseline at 12 months was 7.51. Moderate or marked lessening of induration in the irradiated breast, pectoral fold and/or supraclavicular fossa was recorded clinically in 8/15 evaluable patients. Twelve out of 19 evaluable patients volunteered that their arms felt softer, and six reported improvements in shoulder mobility at 12 months. No significant improvements were noted in patient self-assessments of quality of life.

CONCLUSION:

Interpretation is limited by the absence of a control
group. However, measurement of limb volume by perometry is reportedly reliable, and lymphoscintigraphy is assumed to be operator-independent. Taking all data into account, there is sufficient evidence to justify a double-blind randomised controlled trial of hyperbaric oxygen in this group of patients.

...............

HOT Trial Summary December 2005

HOT - Randomised phase II trial of hyperbaric oxygen therapy for
patients with chronic arm lymphoedema after radiotherapy for cancer.

NHS REC/04/4/016, ISRCTN00743708, EudraCT No 2004-004952-38

Aim
The primary aim is to test the efficacy of hyperbaric oxygen (HBO)
therapy in reducing arm lymphoedema in patients suffering long-term
adverse effects of high dose radiotherapy for cancer. A secondary aim is to test mechanisms of tissue reperfusion and healing in response to HBO.

Endpoints
Primary endpoint: Volume of the affected limb expressed as a percentage of the contralateral limb volume on the day of measurement.

Secondary endpoints: i) Patient self-assessments using a specific quality of life scale in upper limb lymphoedema together with the UK SF-36 Health Survey Questionnaire. ii) 99Tc-nanocolloid clearance rate measured by quantitative lymphoscintigraphy. iii) Extracellular water content of swollen arm (bioimpedance measurements).

Trial design
Randomised controlled trial. All interested volunteers will be referred to Prof Yarnold at the Royal Marsden Hospital, from where relevant medical information will be retrieved and eligibility criteria checked.

If a patient looks suitable on paper, eligibility and pre-treatment
assessments will be arranged for her either at the Royal Marsden
Hospital in Sutton or at the Princess Royal Hospital/Castle Hill
Hospital in Hull, depending on where the patient lives. Patients
eligible for the study will be randomised by Prof Yarnold's team
using a 2:1 ratio of treatment:control, but a record of referring
centres will be maintained and sent to the NCRN.

Trial intervention

Treatment group: hyperbaric oxygen therapy
Patients are compressed to 2.4 ATA (243 kPa) while sitting in a
multiplace Category 1 hyperbaric chamber. Patients breathe 100% oxygen at pressure via a transparent hood. The total time at 2.4 ATA is 100 minutes. Oxygen is breathed for 90 minutes, interrupted by a 5 minutes 'air break' after 30 and 60 minutes. During the final 10 minutes of oxygen breathing, the chamber is depressurised to ambient atmospheric pressure at a linear rate (14.3 kPa/min). Each participant will receive a total of 30 pressure exposures (five days per week for six weeks).

Control group: best standard care
Patients continue treatment according to best standard management as
defined by the trial protocol.

Protocol modifications

In January this year we expanded the criteria for the trial to include patients who presented with T4 (previously T1-3) cancers, provided they have been disease-free for at least 5 years prior to trial entry. At the same time, we decided to include patients who had received radiotherapy to their SCF only (previously axilla +/- SCF). In July we obtained MREC permission to include patients who have developed arm lymphoedema following radiotherapy treatment for Hodgkin Lymphoma.

Status

Open to accrual since January 2005. 24 patients have so far been
randomised into the study, 15 to the treatment arm and 9 to the control arm. This meets the target rate of 3 patients per month, and we expect to meet our total target of 63 volunteers by the end of 2006.

Collaborating centres
Royal Marsden Hospital, Sutton.
Hyperbaric Unit, BUPA Hospital Hull & East Riding, Kingston-upon-Hull.

Diving Diseases Research Centre, Plymouth.
Hyperbaric Medicine Unit, Royal Hospital Haslar, Gosport.
London Hyperbaric, Whipps Cross University Hospital, Leytonstone,
London.

Chief Investigator
John Yarnold, Professor of Clinical Oncology, Royal Marsden Hospital.

Trial Coordinator
Lone Gothard, Academic Radiotherapy Dept, Royal Marsden Hospital, Downs
Road, Sutton SM2 5PT. Tel: 020 8661 3460. Email: lone.goth...@icr.ac.uk

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HIGH-PRESSURE OXYGEN THERAPY FOR ARM SWELLING

Version 4 / July 2005

HOT

HIGH-PRESSURE OXYGEN THERAPY FOR ARM SWELLING
CAUSED BY TREATMENT FOR CANCER

(Randomised phase II trial of hyperbaric oxygen therapy for patients
with
chronic arm lymphoedema after radiotherapy for cancer)

Patient Information Sheet

We would like to invite you to take part in a research study. Before
you decide it is important for you to understand why the research is
being done and what it will involve. Please take time to read the
following information carefully and discuss it with friends, relatives and your GP if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

1. What is the purpose of the study?
A minority of people experience long-lasting and troublesome
consequences of treatment for cancer. One of them is radiation
fibrosis, the name given to scar tissue. Fibrosis in the armpit is
thought to be responsible for narrowing of the fine lymph channels that normally drain fluid from the arm. This can lead to swelling of the arm, a condition called lymphoedema. As you already know, this can be a disabling and distressing problem for which there is no known effective medical treatment. A pilot study suggests that high-pressure oxygen may improve established arm lymphoedema caused by radiotherapy for breast cancer. High-pressure oxygen is a safe treatment with few side effects, and if it can help healing tissue damaged by radiotherapy, it would be a major advance in treatment. A clinical trial has been designed to show whether high-pressure oxygen has beneficial effects in patients with arm lymphoedema caused by radiotherapy.

2.Why am I being invited to take part?
You have arm swelling following your treatment for cancer. We are
looking for 63 volunteers with this condition for our research study
who had their treatment at least 2 years ago, who are now free of
cancer and who would be able to attend assessments at the Royal Marsden Hospital in Sutton or Princess Royal Hospital in Hull. Volunteers must also be willing and able to attend six weeks of high-pressure (hyperbaric) oxygen treatment at one of the modern hyperbaric medicine facilities in Gosport, Hull, London or Plymouth.

3.Do I have to take part?

It is up to you to decide whether or not to take part. If you decide to take part you will be given this information sheet to keep and you will be asked to sign a consent form. If you decide to take part you are still free to change your mind or withdraw at any time and without giving a reason. This will not affect the standard of treatment or care you receive.

4. What will happen to me if I take part?

The study is called a randomised trial. It compares volunteers given
high-pressure oxygen therapy (the test group) with volunteers who are not given high-pressure oxygen (the control group). All volunteers will be monitored by a specialist lymphoedema nurse at the assessment centre for 3 months prior to the study to ensure that the same standard care is delivered to all patients throughout the study period.

Volunteers in the test group will be treated on 30 occasions in a
hyperbaric chamber with 100% oxygen at 2.4 atmospheres pressure.
Volunteers in the control group will continue to have standard
management for arm swelling. The allocation of volunteers to test group or control group is random, and decided by a computer in our trials office, not by the patients or their doctors. 42 patients will be included in the test group (high-pressure oxygen therapy), and the other 21 will be allocated to the control group (standard care).

If you are interested in the study, we will ask you to complete a
general health questionnaire. We will also ask for your permission to contact your family doctor and cancer specialist to obtain any medical information required to assess your suitability for the study. If it looks as if you are eligible and suitable, and if you decide that you would like to participate, we will ask you to complete a self-assessment questionnaire which will give us a clear picture of how your arm swelling affects your day to day activities and quality of life. We will then invite you to the following pre-treatment assessments:-

ALL VOLUNTEERS

At your first visit to the assessment centre the trial co-ordinator
will explain the study to you in detail and answer any questions you
may have. A lymphoedema nurse will assess your arm swelling and discuss the management you are currently receiving. It is important for the outcome of the study that all volunteers receive the same standard therapy, and the nurse may therefore offer you additional advice about your care. At this visit we will ask for your written consent to participate in the study. This will enable us to enter you into the study and to let you know if you have been selected to undergo high-pressure oxygen therapy (test group) or continue standard care (control group).

Approximately 3 months later, we will ask you to attend the assessment centre for a second assessment. Your arms will be measured again, and this measurement will be the baseline for our study. We will also assess the water content in your affected arm compared to your other arm. This will be done with an EdemaMeter, which is a measuring instrument with a handheld probe (similar to the probes used during an ultrasound scan). This is a completely painless procedure and takes altogether about 20 minutes to perform.

At this visit we would also like to test the function of the lymphatic vessels in your arm (lymphatic vessels carry tissue fluid out of the arm). This will help us understand the way in which high-pressure oxygen treatment may improve lymphoedema and thereby, hopefully, help us improve the management of this difficult condition in the future.

The test we use is called lymphoscintigraphy, and in order to be able to detect any improvement in lymphatic function as a result of the high-pressure oxygen treatment, we will need to perform the test twice: before treatment and one year later. It is important that volunteers in the control group have these scans as well in order to compare the results with results from volunteers in the test group.

The test involves the injection of a tiny amount of a radioactive substance (technetium-99m labelled Nanocol) just under the skin of the forearm on both sides. This is performed under sterile conditions, and any discomfort should be minor and momentary only.

You will be asked to sit in front of a machine called a gamma camera for a few minutes so that your arms can be scanned. This will be repeated at 30-minute intervals for a total of 3 hours. In-between taking these images, you will be able to sit in the waiting area. The dose of radioactivity you receive on each occasion is about the same as 4 months' exposure to background radiation from natural sources in the environment.

Lymphoscintigraphy is a routine test for lymphoedema and it has a proven track record of safety. Although there is a theoretical risk of inducing infection by this test, experience indicates that any such risk is very small.

The next step depends on which group you have been selected for, test group (high-pressure oxygen therapy) or control group (standard care):

If you are selected for the TEST GROUP:

We will arrange for you to have a magnetic resonance imaging (MRI) scan of your upper body to confirm that there are no reasons why you should not have hyperbaric oxygen (see below). We will then arrange for you to visit the Royal Hospital Haslar in Gosport, the Hyperbaric Medical Centre in Plymouth, Whipps Cross Hospital in London or the BUPA Hospital in Hull, depending on which centre is nearest to where you live. Here a specialist in high-pressure oxygen therapy will assess your fitness for hyperbaric oxygen treatment and arrange for you to have a chest x-ray. At the same time, you will be introduced to the staff at the hyperbaric medicine unit, and have the opportunity to familiarise yourself with the high-pressure oxygen chamber where the actual treatment takes place.

If you are accepted for the study after these assessments, we will
contact you with the dates for your high-pressure oxygen treatment at the hyperbaric facility most convenient to you.

What is the treatment?
High-pressure oxygen treatment is given once a day, five days a week, for six weeks (total 30 treatments). Seven patients can sit comfortably in the high-pressure oxygen chamber at the same time.

The chambers are the most advanced of their kind and are quite large - roughly 7 feet from floor to ceiling and 14 feet long, with small windows. A qualified attendant is in the chamber at all times to monitor the physical and psychological wellbeing of patients. A doctor is also immediately available outside the chamber.

Each treatment lasts a little over 90 minutes. Pretend for a moment
that you are having one of these treatments. As the air pressure rises in the chamber, the air becomes warm and you notice a slight change in how your voice sounds. You wear earmuffs for several minutes at this stage because the air pumps make a noise. As the pressure increases, you need to "equalise" your ears (rather like descending in an airliner) and the staff in the chamber with you will show you how to do this. The pressurisation of the chamber will be stopped instantly if anyone experiences problems.

Once the chamber is fully pressurised, you put on a large transparent plastic hood that fits over your head, and you start to breathe pure oxygen. The hood allows you to read and to speak normally. Every 30 minutes you have a 5-minute break in the chamber breathing without the hood. After 90 minutes the chamber gradually returns to normal atmospheric pressure. You notice the air in the chamber becoming cooler. Your ears equalise easily without effort during the decompression (you may hear them "popping" like going up in an aircraft), but again the process can be halted at any time if you have any problems.

If you have problems equalising your ears because of a cold or other
chest infection, you will be offered a standard decongestant
medication. If you are still unable to equalise, you will be offered
the choice of either withdrawing from the trial or undergoing a routine minor surgical procedure under local anaesthesia to make a small opening in the eardrum. This procedure is performed by a medical specialist in ear, nose and throat surgery, and your written
fully-informed consent would be obtained first.

What are the possible side effects?

Oxygen treatment in a high-pressure chamber has a proven safety record, especially at the relatively low pressures that will be used for this study. Many patients are routinely treated in this way, including some who are critically ill, unconscious and on a life-support machine.

People having repeated treatments with high-pressure oxygen therapy
sometimes notice a feeling of increased fatigue or tiredness. This
effect is apparent later in the day after a treatment in the morning, and disappears by the following day. It is rarely, if ever, enough to interfere with normal daily activities.

A very rare side effect of breathing oxygen at the pressure used is
having a fit (seizure). This is short-lived and easily dealt with by
removing the hood. There are no lasting effects. You may not be
eligible to take part if you have had any seizures in the past, as this may predispose you to having an oxygen seizure.

The changes in pressure can cause damage to the middle ear or sinuses if the pressures in them are not equalised. This may cause pain and/or a ruptured eardrum, which generally heals within a week. It can be prevented easily by notifying the attendant that you have a problem, and the compression or decompression can be stopped immediately. It is also possible for fluid to accumulate in the middle ear over the course of high-pressure treatments which usually resolves without any specific treatment.

If there are abnormalities in the lung, or the person holds her breath during depressurisation, it is possible for gas bubbles to enter the blood and travel to the brain, causing problems similar to a stroke. The treatment is immediate recompression. Alternatively, the expanding gas can burst through the lining of the lung into the chest cavity, causing the lung to collapse. The treatment is removal of the air through a drainage tube placed though the chest wall.

These complications are extremely unlikely with the slow pressure changes used in this study. They will be avoided by carefully screening participants for lung problems, and by breathing normally at all times.

When people are exposed to increased pressure and that pressure is
reduced too rapidly, it is possible for gas bubbles to form in blood
and body tissues, causing decompression illness (this may happen to
divers and is sometimes called "the bends"). The most common symptom is pain in or around a joint, but in more severe cases nervous system problems can occur. The risk of this is extremely low in the controlled environment of a high-pressure chamber where the pressure is reduced slowly. In fact, decompression illness is normally treated in a high-pressure chamber.

Some people notice temporary changes in their vision over the course of many treatments. A change in the shape of the lens may cause a mild degree of short-sightedness, which may improve or worsen vision, depending on any pre-existing short- or long-sightedness. If this does occur, you can expect it to have returned fully to normal within six weeks of finishing treatment.

The high-pressure chamber is a relatively confined space and it
occasionally induces feelings of claustrophobia. About one person in
fifty may be affected. If you are, please remember that you are in
control at all times and that you can leave the chamber at any time,
without affecting any of the other participants.

We have considered the theoretical possibility that high-pressure
oxygen therapy might stimulate dormant cancer cells but there is no
evidence that it does so. This therapy is commonly used in patients
with a past history of other cancer. The MRI scan you will have on
entering the trial is partly to ensure that no cancer tissue is
visible.

What are the possible benefits of taking part?

We hope that the treatment will reduce the swelling of your arm and
improve symptoms like shoulder stiffness and hardened tissue in the
areas where you had your radiotherapy treatment. However, this cannot be guaranteed. The information we get from this study may help us to treat future patients with radiation fibrosis and arm swelling better. You will be told about any important new information that might affect your willingness to take part. If at any time, the researchers consider it in your best interest, they will withdraw you from the study. They will explain the reasons and arrange for your follow up to continue in the usual way.

Follow-up assessments

12 months after the start of your high-pressure oxygen treatment we
will ask you to attend follow up assessments at the assessment centre.

At this visit we will repeat the volume measurements of your arms as
well as the water content measurements, and we will ask you to have a second lymposcintigraphy scan. In addition, self-assessment
questionnaires will be posted to you at home 3, 6, 9, 12 and 15 months after you entered the study.

Skin biopsies - treatment group

Because so little is known about the mechanisms of high-pressure oxygen therapy in improving arm swelling, it is important that we collect as much information as possible for our research. We think that high-pressure oxygen can help healing tissue damaged by radiotherapy by stimulating the growth of new or damaged blood vessels (capillaries) and thereby improving the blood supply to the affected area. However, if and when this mechanism is activated is unclear, and we would like to investigate this further.

It would therefore add greatly to the value of the research if you
would give us your written consent to provide some very small skin
samples (biopsies) from an area within the irradiated area of your
chest and from a corresponding area on the other side for comparison.

We would also like to take a very small skin sample from the underside of both of your forearms. The biopsies are done under a local anaesthetic before treatment and repeated between day 5 and 15 of your treatment. The fragments of tissue are taken within an area less than the size of a new one penny-piece (each fragment of tissue is the size of a grain of rice and only takes a few seconds to collect). A surface dressing is provided for 7 days until the skin heals. You can wash freely and swim because the dressing is waterproof. Side effects include slight discomfort whilst the local anaesthetic is introduced under the skin. There is a very small risk of infection that may need to be treated by antibiotics, and a bruise sometimes develops, but the area quickly heals leaving only a small scar.

If you are selected for the CONTROL GROUP:

Being a member of the control group is as important to the research as being in the test group. We will ask you to continue the care you have agreed with the lymphoedema nurse and to attend a follow up clinic at the assessment centre 15 months after your randomisation into the study. At this visit we will repeat the volume measurements of your arms as well as the water content measurements, and we will ask you to have a second lymposcintigraphy scan. In addition, self-assessment questionnaires will be posted to you at home 3, 6, 9, 12 and 15 months after you entered the study.

Skin biopsies - control group

As well as collecting tissue samples from volunteers undergoing
high-pressure oxygen therapy, we would also like to collect samples
from volunteers in the control group. These samples would act as
controls to the tissue samples collected from the volunteers in the
treatment group and would be taken from the same sites and using the
same procedures as described above. The biopsies would be done under a local anaesthetic when you attend for your first assessment and
repeated around the time of your baseline assessment 3 months later.

The remainder of this information sheet refers to All VOLUNTEERS.

5. What is the expense of volunteering?

None. The cost of hyperbaric oxygen treatment will be covered by a
research grant. This also covers travel costs for assessments and
treatment for all volunteers.

6. Will I be paid for taking part in this study?

No. Neither you nor your doctor will be paid for taking part.

7. Are there any restrictions on what I might eat or do?

No.

8. What if something goes wrong?

Your progress will be watched closely during and after treatment and
you will be offered whatever treatment is available to help with any
side effects. We do not believe you will suffer any injury from
participating in this study. You should however know that if you are
harmed by taking part, there are no special compensation arrangements.

If you are harmed due to someone's negligence than you have grounds
for legal action. Regardless of this, if you have any cause to complain about any aspect of the way you have been approached or treated, the normal NHS complaints mechanism is open to you. Your hospital will have a formal complaints procedure that is available to you.

9. Are there other ways of treating this condition?

Elastic hosiery, exercise, massage and, in severe cases, compression
bandaging can be used to manage and control the swollen limb, but there is no known effective treatment for arm lymphoedema.

10. Confidentiality - who will know I am taking part in the study?

All information that is collected about you during the course of the
research will be kept strictly confidential. When you enter the study your name will be passed to the Clinical Trials Unit at The Institute of Cancer Research who is responsible for the randomisation. After that, all trial documentation will have your name removed and you will be identified by a unique trial number.

11. GP notification

We will ask for your permission to inform your GP about the study and your participation in it.

12. What will happen to the results of the research study?

The results will be submitted for publication in the scientific
literature. They will be conveyed to volunteers in a written report,
approximately 3 years after the trial starts (1 year after the last
patient is treated). Our research grant only covers high-pressure
oxygen therapy for the 42 volunteers in the treatment group. If the
treatment proves successful, we will therefore not be able to offer it to the volunteers in the control group. If you were in the control group, and the treatment proves successful, it would therefore be your primary care trust's decision whether or not to refer you for high-pressure therapy.

13. Who is organising the study and how is the data collected and stored?

The study is being organised by Professor John Yarnold, Consultant
Clinical Oncologist in collaboration with Professor Peter Mortimer,
Consultant Dermatologist, both at the Royal Marsden Hospital in Sutton. The research is being funded by Cancer Research UK and is expected to start in April 2004 and finish three years later.

The results from your therapy and the information collected through the patient self-assessment questionnaires will be stored and analysed by a trial statistician in the Clinical Trials and Statistics Unit at the Institute of Cancer Research. The tissue samples will be stored at the Institute of Cancer Research in small containers identified with your trial number, initials and the date the tissue was taken. They will be kept in a secure fashion for 20 years and made available to researchers working to investigate the mechanisms of high-pressure oxygen treatment and radiotherapy only. Professor Yarnold, who is the Chief Investigator for the study, will maintain the control of the data and the tissue samples.

14. Who has reviewed the study?

We have approval for the study from the Trent Multi-centre Research
Ethics Committee and the local research ethics committees at the
hospitals and institutions involved in the research. All research that involves NHS patients or staff, information from NHS medical records or uses NHS premises or facilities must be approved by a NHS Research Ethichs Committee before it goes ahead. Approval does not guarantee that you will not come to any harm if you take part.

However, approval means that the Committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits, and that you have been given sufficient information on which to make an informed decision to take part or not.

15. What if I have any concerns?

If you have any concerns or other questions about this study or the way it has been carried out, you should contact the Principal Investigator, Professor John Yarnold, or you may contact the complaints department at the Royal Marsden Hospital (please see contact details below).

16. Contact for further information

It is possible that you may be able and willing to help with this
research. If you are interested to know more, please examine carefully the points listed overleaf:-

To be suitable for the trial, you must:-

1. Have marked arm swelling (lymphoedema) following radiotherapy for
cancer.

2. Provide written informed consent to participate in the study and be available for follow up.

3. Be able to attend assessments at the Royal Marsden Hospital in
Sutton or Princess Royal Hospital in Hull.

4. Be prepared to have an MRI scan before high-pressure treatment.

5. Be able to attend 6 weeks of high-pressure treatment at your nearest hyperbaric medicine facility.

Please note that the following criteria will mean that you are not suitable for the trial:-

1. Previous high-pressure oxygen therapy (excluding treatment for
decompression illness).

2. Chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated
pneumothorax.

3. Previous ear operations, eustachian tube dysfunction (inability to equalise middle ear pressure) or recurrent attacks of vertigo.

4. Any contra-indication to magnetic resonance imaging (MRI) (e.g.
intracranial ferrous material).

5. Any sign of active cancer in the past 24 months.

If you think you might be suitable for this study and are prepared to take things a stage further, please complete the enclosed reply form and return it in the envelope provided. The information you provide will be treated as completely confidential.

For further information please contact:-

Professor John Yarnold (Consultant) or
Mrs Lone Gothard (Research Co-ordinator)

Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PL
Telephone: 020 8661 3460
Fax: 020 8661 3107
Email: lone.goth...@icr.ac.uk

Thank you very much for your help in this matter.

Date letter given to patient: ____ / ____ / ____

REPLY FORM

HOT

HIGH-PRESSURE OXYGEN THERAPY FOR ARM SWELLING
CAUSED BY TREATMENT FOR BREAST CANCER

(Randomised phase II trial of hyperbaric oxygen therapy for patients
with chronic arm lymphoedema after radiotherapy for early breast cancer)

Consent to Provide Medical Information

I think I might be suitable for this study, and I consent to my general practitioner and/or hospital cancer specialist making my medical details available to medical members of the expert panel involved in this research project.

Your signature ________________________________________

Date ____ /
____ / ____

Your full name _____________________________________________________________

Address _____________________________________________________________

_____________________________________________________________

Telephone No _____________________________________________________________

Please provide the following names and addresses:

Your general practitioner (family doctor)

Name _____________________________________________________________

Address _____________________________________________________________

_____________________________________________________________

Telephone No _____________________________________________________________

Your cancer specialist (clinical oncologist / radiotherapist)

Name _____________________________________________________________

Hospital _____________________________________________________________

Address _____________________________________________________________

_____________________________________________________________

Your Hospital No _________________________________________________________


..................

A very good question regarding hyperbaric oxygen treatment was raised in one of the online support groups...

"I've heard that hyperbaric oxygen causes tumor growth and can spread cancer, is that true?"

Actually, ther are clinical studies that indicate this is not true.

Below is an abstract from:

Pub Med

http://www.ncbi.nlm.nih.gov/entrez/quer ... t=Citation

May 2005

Effects of hyperbaric oxygen exposure on experimental head and neck tumor growth, oxygenation, and vasculature.

Shi Y, Lee CS, Wu J, Koch CJ, Thom SR, Maity A, Bernhard EJ.

Department of Radiation Oncology, University of Pennsylvania, 195 John Morgan Building, 37th and Hamilton Walk, Philadelphia, PA 19104-6072, USA.

BACKGROUND: Hyperbaric oxygen (HBO2) is used to promote healing in irradiated tissues, but concern persists about the possibility that it may promote residual tumor growth. METHODS: The tumor growth of SQ20B and Detroit 562 head and neck squamous cell carcinoma xenografts were studied after single-dose irradiation and 5x/week HBO2 treatment at 2.4 atm absolute for 90 minutes. The effect of HBO2 treatment on tumor hypoxia and vasculature was also examined by immunohistochemical analysis. RESULTS: HBO2 treatment increased tumor oxygenation during the treatment interval but did not promote the growth of either irradiated or unirradiated tumors. No increase in tumor vascular endothelial growth factor expression or vascularization was detected. CONCLUSIONS: This study found no evidence for persistent changes in tumor microenvironment or tumor growth promotion caused by hyperbaric oxygen exposure. 2005 Wiley Periodicals, Inc.

MeSH Terms:
Animals
Carcinoma, Squamous Cell/blood supply*
Carcinoma, Squamous Cell/metabolism*
Carcinoma, Squamous Cell/pathology
Cell Hypoxia
Dose-Response Relationship, Radiation
Head and Neck Neoplasms/blood supply*
Head and Neck Neoplasms/metabolism*
Head and Neck Neoplasms/pathology
Hyperbaric Oxygenation*
Immunohistochemistry
Male
Mice
Mice, Nude
Neoplasms, Experimental
Neovascularization, Pathologic
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.
Transplantation, Heterologous
Vascular Endothelial Growth Factor A/metabolism

Substances:
Vascular Endothelial Growth Factor A

Grant Support:
P50 AT000428/AT/NCCAM
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Hyperbaric Oxygen

Postby ro81nm » Mon Sep 25, 2006 5:58 pm

I actually was part of a Hyperbaric Oxygen study at U Penn Hospital. I'm not sure that I have noticed a huge difference in my arm, but it made the constant pain go away. My doctor said that the results may be slow, so I'm still hoping! It was a great study, although be prepared for your life to be completely interupted for a few weeks!
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