Hyperbaric oxygen for chronic radiation cystitis
Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
This project will try hyperbaric oxygen therapy in adults with moderate to severe radiation cystitis to see if symptoms improve and urine inflammatory markers change.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT07368647 on ClinicalTrials.gov |
What this trial studies
This observational project enrolls adults who developed moderate to severe radiation cystitis after pelvic radiotherapy and who are scheduled to start or recently started hyperbaric oxygen therapy as part of their care. It collects urine, blood, and tissue samples and patient-reported symptom measures before, during, and after therapy to track inflammatory biomarkers and symptom trajectories. Cystoscopy, urine cytology, and biopsy are used per standard of care to exclude infection and urothelial malignancy. The aim is to link biological markers with patient-reported outcomes to better understand who benefits from hyperbaric oxygen.
Who should consider this trial
Good fit: Adults (≥18) with moderate to severe radiation cystitis and recurrent visible hematuria after pelvic radiation, without infection or urothelial malignancy, who are scheduled for or have recently started hyperbaric oxygen therapy.
Not a fit: Patients with active urinary tract infection, confirmed bladder cancer, only mild or no hematuria, or who are not receiving hyperbaric oxygen are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the findings could help predict which patients will gain symptom relief from hyperbaric oxygen and guide more personalized treatment.
How similar studies have performed: Prior clinical reports and smaller trials have shown that hyperbaric oxygen can improve symptoms of radiation cystitis, but studies linking treatment to urine inflammatory biomarkers are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cohort 1 * At least 18 years of age * Post pelvic radiation carrying the diagnosis of moderate to severe radiation cystitis and recurrent macroscopic hematuria in the absence of infection or urothelial malignancy. The diagnosis of moderate to severe (Radiation Therapy Oncology Group (RTOG) grade 2, 3-4) RC will be made by board-certified, reconstructive Urologists routinely managing radiation cystitis patients in their practices (RM /WB,III) or co-investigator (JB) using Appendix B and confirmed with cystoscopy and negative urine cytology and/or bladder biopsy to rule out malignancy (which is standard of care of work up of hematuria as defined by the American Urology Association)45 once all other pathologies for gross hematuria have been excluded (including infection, malignancy, etc). * Scheduled to, or currently undergoing (initiated within the past 7 days), HBOT as part of standard of care therapy for radiation cystitis Cohort 2 HBOT controls * At least 18 years of age * Without a history of prior pelvic radiation * Scheduled to, or currently undergoing (initiated within the past 7 days) HBOT as part of standard of care therapy for reasons that do not include bladder inflammation) Cohort 3 Healthy controls * At least 18 years of age * Without history of pelvic radiation or HBOT Cohort 4 * At least 18 years of age * Same as Cohort 1 except they OPT-OUT of participation in HBO therapy. Exclusion Criteria: All Cohorts * Pregnant or lactating (females will be asked if there is any chance they could be pregnant). * Uncompensated heart failure, uncompensated fluid overload, or uncompensated myocardial infarction preventing therapeutic HBOT * A history of: uncontrolled seizure disorder, active urinary tract infection, active Grave's disease, cystic fibrosis, sickle cell anemia, known HIV, or any autoimmune disease not in remission that requires active systemic steroid therapy or immune modulating medications. * Refusal to sign IRB approved informed consent document * Prior participation in a clinical trial that could potentially affect immunological status
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Study coordinator: Rachel Moses, MD
- Email: Rachel.A.Moses@hitchcock.org
- Phone: (603) 650-5091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.