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

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT01087268

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Masking:

Double

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)

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2011

Outcome Measures

Primary Outcome Measures

Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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