Hyperbaric oxygen for chronic radiation cystitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.