RECRUITINGOBSERVATIONAL
Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
About This Trial
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy (HBOT) is the only non-invasive treatment modality for Radiation Cystitis, performed by placing patients in chambers and introducing them to steep oxygen gradients (100% oxygen at a pressure of 240-250kPa) for 80 to 90 minutes per day in up to 60 consecutive sessions.
Locations (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States