Prostate Cancer Clinical Trial
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)
Verified date | March 2010 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Marsden - Surrey | Sutton | England |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire | No | ||
Secondary | Physician assessment of adverse effects using LENT SOMA scales of radiation injury | Yes | ||
Secondary | Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38 | No | ||
Secondary | Photographic images of rectal mucosa | No | ||
Secondary | Physician assessment of rectal dysfunction based on the modified CTCAE grading system | No | ||
Secondary | Health economics data | No |
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