Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Royal Marsden NHS Foundation Trust
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01087268
First received: March 13, 2010
Last updated: July 14, 2011
Last verified: March 2010
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
MedlinePlus related topics:
Benign Tumors
Bladder Cancer
Cancer
Cervical Cancer
Colorectal Cancer
Ovarian Cancer
Oxygen Therapy
Prostate Cancer
Soft Tissue Sarcoma
Testicular Cancer
Vaginal Cancer
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 75 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087268
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01087268 History of Changes |
| Other Study ID Numbers: | CDR0000667367, RMH-CCR3086, EUDRACT-2008-002152-26, EU-21010, MREC-08/H0903/40 |
| Study First Received: | March 13, 2010 |
| Last Updated: | July 14, 2011 |
| Health Authority: | Unspecified |
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:
|
Urinary Bladder Neoplasms Endometrial Neoplasms Uterine Cervical Neoplasms Colorectal Neoplasms Ovarian Neoplasms Prostatic Neoplasms Vaginal Neoplasms Neoplasms, Germ Cell and Embryonal Adenoma Radiation Injuries Pelvic Neoplasms Sarcoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases Uterine Neoplasms Genital Neoplasms, Female Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013