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

• ClinicalTrials.gov Identifier: NCT01087268
• Recruitment Status: Unknown
• First Posted: March 16, 2010
• Last Update Posted: July 15, 2011
• Sponsor: Royal Marsden NHS Foundation Trust
• Information provided by: National Cancer Institute (NCI)

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 (Clinical Trial)
• Estimated 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: January 2009
• Estimated Primary Completion Date: December 2011

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire

Secondary Outcome Measures :

1. Physician assessment of adverse effects using LENT SOMA scales of radiation injury
2. Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38
3. Photographic images of rectal mucosa
4. Physician assessment of rectal dysfunction based on the modified CTCAE grading system
5. Health economics data

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United Kingdom

Royal Marsden - Surrey; Recruiting

Sutton, England, United Kingdom, SM2 5PT

Contact: Contact Person 44-20-8661-3388

Sponsors and Collaborators

Royal Marsden NHS Foundation Trust

Investigators

• Principal Investigator: John R. Yarnold, MD, FRCR; Royal Marsden NHS Foundation Trust

More Information

• ClinicalTrials.gov Identifier: NCT01087268 History of Changes
• Other Study ID Numbers: CDR0000667367; RMH-CCR3086; EUDRACT-2008-002152-26; EU-21010; MREC-08/H0903/40
• First Posted: March 16, 2010
• Last Update Posted: July 15, 2011
• Last Verified: March 2010

Keywords provided by National Cancer Institute (NCI):

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 I endometrial carcinoma; stage II endometrial carcinoma; stage III endometrial carcinoma; stage I uterine sarcoma

Additional relevant MeSH terms:

Prostatic Neoplasms; Sarcoma; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Neoplasms, Germ Cell and Embryonal; Endometrial Neoplasms; Vaginal Neoplasms; Pelvic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Vaginal Diseases