Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiat… (NCT01087268) | Clinical Trial Compass
UnknownPhase 3
Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer
United Kingdom75 participantsStarted 2009-01
Plain-language summary
RATIONALE: Radiation therapy can cause long-term adverse effects. Hyperbaric oxygen therapy may be effective in lessening gastrointestinal symptoms caused by radiation therapy given for pelvic cancer. It is not yet known whether high-pressure oxygen is effective in treating adverse effects caused by radiation therapy.
PURPOSE: This randomized phase III trial is studying hyperbaric oxygen therapy to see how well it works in treating long-term gastrointestinal adverse effects caused by radiation therapy in patients with pelvic cancer.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Past history of rectal, prostate, testicular, bladder, uterine cervix, uterine corpus, vaginal, or ovarian cancer
* Malignant disease (T1-3, N0-1, M0)
* No evidence of cancer recurrence
* Gastrointestinal symptoms attributable to prior radiotherapy received at least 1 year ago, meeting 1 of the following criteria:
* Grade 2 or higher in any Late Effects in Normal Tissues Subjective, Objective, Management, and Analytic Scales (LENT SOMA) category
* Grade 1 with difficult intermittent symptoms
* Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period
PATIENT CHARACTERISTICS:
* Must be physically and psychologically fit to undergo hyperbaric oxygen therapy
* No claustrophobia
* No epilepsy
* No chronic obstructive airway disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, or untreated pneumothorax
* No previous middle/inner ear operations (except grommets and similar procedures) and/or inability to equalize middle ear pressure
* No contraindication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior surgery for rectal cancer
* No prior hyperbaric oxygen therapy (excluding treatment for decompression illness)
* No prior treatment with bleomycin
What they're measuring
1
Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire