Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer
Recruitment status was Recruiting
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.
Long-term Effects Secondary to Cancer Therapy in Adults
Testicular Germ Cell Tumor
Other: questionnaire administration
Procedure: gastrointestinal complications management/prevention
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||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)|
- Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||January 2009|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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.
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Contact Person 44-20-8661-3388|
|Principal Investigator:||John R. Yarnold, MD, FRCR||Royal Marsden NHS Foundation Trust|