Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer
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ClinicalTrials.gov Identifier: NCT01087268 |
Recruitment Status : Unknown
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : March 16, 2010
Last Update Posted : July 15, 2011
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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 |
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 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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087268
United Kingdom | |
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 |
ClinicalTrials.gov Identifier: | NCT01087268 |
Other Study ID Numbers: |
CDR0000667367 RMH-CCR3086 EUDRACT-2008-002152-26 EU-21010 MREC-08/H0903/40 |
First Posted: | March 16, 2010 Key Record Dates |
Last Update Posted: | July 15, 2011 |
Last Verified: | March 2010 |
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 |
Prostatic Neoplasms Sarcoma Uterine Cervical Neoplasms Urinary Bladder Neoplasms Endometrial Neoplasms Neoplasms, Germ Cell and Embryonal Vaginal Neoplasms Pelvic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Prostatic Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Genital Neoplasms, Female Uterine Neoplasms Uterine Cervical Diseases Uterine Diseases Urologic Neoplasms Urinary Bladder Diseases Urologic Diseases Vaginal Diseases |