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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Double-Blind Controlled Phase III Trial of Hyperbaric Oxygen Therapy in Patients Suffering Long-Term Adverse Effects of Radiotherapy for Pelvic Cancer (HOT II)

Conditions
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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

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: gastrointestinal complications management/prevention
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: gastrointestinal complications management/prevention|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician assessment of adverse effects using LENT SOMA scales of radiation injury |  |  | 
| Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38 |  |  | 
| Photographic images of rectal mucosa |  |  | 
| Physician assessment of rectal dysfunction based on the modified CTCAE grading system |  |  | 
| Health economics data |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I endometrial carcinoma, gastrointestinal complications, radiation toxicity, long-term effects secondary to cancer therapy in adults, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, stage I bladder cancer, stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage I vaginal cancer, stage II vaginal cancer, stage III vaginal cancer, stage I malignant testicular germ cell tumor, stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, stage II endometrial carcinoma, stage III endometrial carcinoma, stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IA ovarian epithelial cancer, stage IB ovarian epithelial cancer, stage IC ovarian epithelial cancer, stage IIA ovarian epithelial cancer, stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IA ovarian germ cell tumor, stage IB ovarian germ cell tumor, stage IC ovarian germ cell tumor, stage IIA ovarian germ cell tumor, stage IIB ovarian germ cell tumor, stage IIC ovarian germ cell tumor, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor