|
Lay title: A trial looking at hyperbaric oxygen (HBO) treatment for people who have long term side effects following radiotherapy for pelvic cancer
This is a multi-centre research collaboration led from The Royal Marsden Hospital by Dr Jervoise Andreyev (Consultant Gastroenterologist in Pelvic Radiation Disease) and Professor John Yarnold (Consultant Clinical Oncologist).
Background
Most patients having radiotherapy to the abdomen or pelvis notice one or more side effects, but these usually clear up once treatment is finished. Once the symptoms have settled, there are, broadly speaking, four long-term outcomes for patients in terms of their bowels: between 10 and 20 of every 100 patients have no long-term symptoms; between 30 and 40 are able to cope with changes in bowel habit that have little impact on daily life, but about 30 patients develop change in bowel function that interfere to some degree with daily activities and long-term quality of life. Finally, a few develop serious problems that can be very difficult to control. At the present time, these bowel symptoms caused by radiotherapy are not reversible, and as more and more patients are cured of their cancer, the overall number of affected individuals increases.
Fortunately, there are signs of progress in treating bowel symptoms caused by radiotherapy. A recent clinical trial of high pressure oxygen therapy (the kind used in divers who get the ‘bends’ and elite footballers after injury), provides evidence that radiotherapy side effects can be improved. (Clarke et Al, Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up, Int J Rad Onc Biol, Vol 72, No 1 pp134-143 2008). We aim to repeat this work in a randomised trial comparing high pressure oxygen treatment with sham treatment. We are looking for volunteers to join us in this ambitious research programme.
Aim
The aim is to test the efficacy of hyperbaric (high pressure) oxygen (HBO) therapy in reducing intestinal symptoms caused by pelvic radiotherapy at least 12 months earlier and which persist despite optimal standard measures.
Trial design
Randomised double-blind controlled phase III trial.
Eligibility
Inclusion criteria
i) Age over 18 years.
ii) Past history of a malignant pelvic neoplasm (T1-3 N0-1 M0), including carcinoma of the rectum, prostate, testis, bladder, uterine cervix, uterine corpus and ovary.
iii) A minimum 12 months follow-up post-radiotherapy.
iv) No evidence of cancer recurrence.
v) Gastrointestinal symptoms attributable to prior radiotherapy : Grade 2 or higher in any LENT SOMA category, or grade 1 with difficult intermittent symptoms
vi) Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period.
vii) Physical and psychological fitness for HBO therapy.
viii) Written informed consent and availability for follow up.
Exclusion criteria
i) Surgery for rectal cancer.
ii) Prior hyperbaric oxygen therapy (excluding treatment for decompression illness).
iii) Prior treatment with even a single dose of bleomycin.
iv) Claustrophobia.
v) Epilepsy.
vi) Chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax.
vii) Previous middle/inner ear operations (except grommets and similar procedures) &/or irremediable inability to equalise middle ear pressure.
viii) Contra-indication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy.
Referral to the study
For more information about the trial, please contact Sue Martin (Trial Coordinator). Tel: 020 8661 3273 Fax: 020 8661 3107 Email
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
|