Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRachel A. Moses
About this trial
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Potential patients will be identified in the clinical during standard of care appointments. Participants in a local hyperbarics medicine registry will be approached for their interest in participating in this study as well. Healthy volunteers will be recruited from postings on public bulletin boards and available local community ListServs. Recruitment materials are reviewed and approved by the local IRB.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hyperbaric Oxygen Therapy
Other interventionHyperbaric 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.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Cohort 1: RC with HBOT1 intervention
Group B: Cohort 2: HBOT Controls1 intervention
Group C: Cohort 3: Healthy Controls0 interventions
Group D: Cohort 4: RC with no HBOT0 interventions
Trial outcomes
Primary outcomes
1
Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration
Change in urinary 8-OHdG measured using validated oxidative stress assays. Reported in ng/mL.
Time frame
Baseline to 12 months post-HBOT2
Urinary Tumor Necrosis Factor-alpha (TNF-α) concentration
Change in urinary TNF-α measured using validated cytokine immunoassays. Reported in pg/mL.
Time frame
Baseline to 12 months post-HBOT3
Urinary Interleukin-6 (IL-6) concentration
Change in urinary IL-6 measured using validated cytokine immunoassays. Reported in pg/mL.
Time frame
Baseline to 12 months post-HBOT4
Urinary Vascular Endothelial Growth Factor (VEGF) concentration
Change in urinary VEGF measured using validated angiogenesis assays. Reported in pg/mL.
Time frame
Baseline to 12 months post-HBOTSecondary outcomes
1
Hematuria events
Number of patient-reported hematuria episodes recorded at baseline, during HBOT, and follow-up.
Time frame
Baseline to 12 months after enrollment2
Urogenital Distress Inventory (UDI) total score
Change in Urogenital Distress Inventory score (range 0-100; higher scores indicate worse urinary distress).
Time frame
Baseline to 12 months after enrollment3
EQ-5D-5L Index Score
Change in EQ-5D-5L index score (range -0.281 to 1.000; higher scores indicate better health-related quality of life).
Time frame
Baseline to 12 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rachel A. Moses
Lead sponsor
Dartmouth-Hitchcock Medical Center
Sponsor institution
Dartmouth-Hitchcock Medical Center
Collaborator
Source ClinicalTrials.gov