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)
18 Years
N/A
Both
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
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire
Safety Issue:
No
Principal Investigator
John R. Yarnold, MD, FRCR
Investigator Role:
Principal Investigator
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
Unspecified
Study ID:
CDR0000667367
NCT ID:
NCT01087268
Start Date:
January 2009
Completion Date:
Related Keywords:
- 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
- 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
- stage II uterine sarcoma
- stage III uterine sarcoma
- stage IA ovarian epithelial cancer
- stage IB ovarian epithelial cancer
- stage IC ovarian epithelial cancer
- stage IIA ovarian epithelial cancer
- stage IIB ovarian epithelial cancer
- stage IIC ovarian epithelial cancer
- stage IIIA ovarian epithelial cancer
- stage IIIB ovarian epithelial cancer
- stage IIIC ovarian epithelial cancer
- stage IA ovarian germ cell tumor
- stage IB ovarian germ cell tumor
- stage IC ovarian germ cell tumor
- stage IIA ovarian germ cell tumor
- stage IIB ovarian germ cell tumor
- stage IIC ovarian germ cell tumor
- stage IIIA ovarian germ cell tumor
- stage IIIB ovarian germ cell tumor
- stage IIIC ovarian germ cell tumor
- 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
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