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

Phase 3

• Conditions: 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

• Registration Number: NCT01087268
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2010-03
• Study First Submitted: 2010-03-13
• Study First Submitted QC: 2010-03-13
• Study First Posted: 2010-03-16
• Last Update Submitted: 2011-07-14
• Last Update Posted: 2011-07-15
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Marsden - Surrey; 🇬🇧 Sutton, England, United Kingdom