Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer

• Physician assessment of adverse effects using LENT SOMA scales of radiation injury [ Designated as safety issue: Yes ]
• Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38 [ Designated as safety issue: No ]
• Photographic images of rectal mucosa [ Designated as safety issue: No ]
• Physician assessment of rectal dysfunction based on the modified CTCAE grading system [ Designated as safety issue: No ]
• Health economics data [ Designated as safety issue: No ]

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.

OBJECTIVES:

• To determine the clinical benefits of hyperbaric oxygen therapy in reducing dysfunction in patients with pelvic cancer developing iatrogenic gastrointestinal symptoms as a result of previous radical pelvic radiotherapy completed at least one year ago.

OUTLINE: This is a multicenter study. Patients are stratified according to center and severity of symptoms (low vs high). Patients are randomized to 1 of 2 treatment arms.

• Arm I (treatment group): Patients undergo hyperbaric oxygen therapy over 90 minutes, 5 days a week, for 8 weeks for a total of 40 treatments. Oxygen at 100% is breathed for 30 minutes, followed by a 5-minute "air break" and a further 30 minutes of breathing oxygen. A further 5-minute "air break" is followed by a further 30 minutes of breathing oxygen. During the final 10 minutes of oxygen breathing, the chamber is depressurized to ambient atmospheric pressure at a linear rate (14.2 kPa/min).
• Arm II (control group): Patients undergo hyperbaric oxygen therapy over 90 minutes, 5 days a week, for 8 weeks for a total of 40 treatments. Oxygen at 21% is breathed for 30 minutes, followed by a 5-minute "air break" and a further 30 minutes of breathing oxygen. A further 5-minute "air break" is followed by a further 30 minutes of breathing oxygen. During the final 10 minutes of oxygen breathing, the chamber is depressurized to ambient atmospheric pressure at a linear rate (3 kPa/min).

Tissue samples from rectal biopsies may be collected and analyzed.

Patients complete questionnaires (Health Economics, Inflammatory Bowel Disease Questionnaire [IBDQ], EORTC Quality of Life [QLQ]-C30, and QLQ-CR38) at baseline and then at 3, 6, 9, and 12 months after the start of treatment.

After completion of study treatment, patients are followed within 14 days and at 10 months.

• Bladder Cancer
• Cervical Cancer
• Colorectal Cancer
• Endometrial Cancer
• Gastrointestinal Complications
• Long-term Effects Secondary to Cancer Therapy in Adults
• Ovarian Cancer
• Prostate Cancer
• Radiation Toxicity
• Sarcoma
• Testicular Germ Cell Tumor
• Vaginal Cancer

• Other: questionnaire administration
• Procedure: gastrointestinal complications management/prevention
• Procedure: quality-of-life assessment

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