Clinical trial · Interventional
Hyperbaric Oxygen Therapy in Treating Long-Term Gastrointestinal Adverse Effects Caused by Radiation Therapy in Patients With Pelvic Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Complications | — | UNRESOLVED | — |
| Long-term Effects Secondary to Cancer Therapy in Adults | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gastrointestinal complications management/prevention | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire
Secondary outcomes (5)
- measure
- Physician assessment of adverse effects using LENT SOMA scales of radiation injury
- measure
- Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38
- measure
- Photographic images of rectal mucosa
- measure
- Physician assessment of rectal dysfunction based on the modified CTCAE grading system
- measure
- Health economics data
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available