NCT07368647 Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
| NCT ID | NCT07368647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rachel A. Moses |
| Condition | Radiation Cystitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-04-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-04-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07368647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation Cystitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07368647 currently recruiting?
Yes, NCT07368647 is actively recruiting participants. Contact the research team at Rachel.A.Moses@hitchcock.org for enrollment information.
Where is the NCT07368647 trial being conducted?
This trial is being conducted at Lebanon, United States.
Who is sponsoring the NCT07368647 clinical trial?
NCT07368647 is sponsored by Rachel A. Moses. The trial plans to enroll 100 participants.