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

NCT ID: NCT01087268

Last Updated: 2011-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31

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.

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; Testicular Germ Cell Tumor; Vaginal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Interventions

questionnaire administration

Intervention Type: OTHER

gastrointestinal complications management/prevention

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

John R. Yarnold, MD, FRCR

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden - Surrey

Sutton, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Contact Person

Role: primary

44-20-8661-3388

Other Identifiers

RMH-CCR3086

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2008-002152-26

Identifier Type: -

Identifier Source: secondary_id

EU-21010

Identifier Type: -

Identifier Source: secondary_id

MREC-08/H0903/40

Identifier Type: -

Identifier Source: secondary_id

CDR0000667367

Identifier Type: -

Identifier Source: org_study_id