Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration
研究概览
简要总结
Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Cohort 1: RC with HBOT
Participants with radiation cystitis schedule for hyperbaric oxygen therapy
干预措施: Hyperbaric Oxygen Therapy (Other)
Cohort 2: HBOT Controls
Participants schedule for hyperbaric oxygen therapy without a history of pelvic radiation
干预措施: Hyperbaric Oxygen Therapy (Other)
Cohort 3: Healthy Controls
Age and gender matched controls with no history of radiation exposure
Cohort 4: RC with no HBOT
Participants with radiation cystitis who elect not to undergo hyperbaric oxygen therapy
结局指标
主要结局
Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration
时间窗: Baseline to 12 months post-HBOT
Change in urinary 8-OHdG measured using validated oxidative stress assays. Reported in ng/mL.
Urinary Tumor Necrosis Factor-alpha (TNF-α) concentration
时间窗: Baseline to 12 months post-HBOT
Change in urinary TNF-α measured using validated cytokine immunoassays. Reported in pg/mL.
Urinary Interleukin-6 (IL-6) concentration
时间窗: Baseline to 12 months post-HBOT
Change in urinary IL-6 measured using validated cytokine immunoassays. Reported in pg/mL.
Urinary Vascular Endothelial Growth Factor (VEGF) concentration
时间窗: Baseline to 12 months post-HBOT
Change in urinary VEGF measured using validated angiogenesis assays. Reported in pg/mL.
Completion of HBOT
时间窗: From enrollment to 1 year after completion of HBOT treatment
Participants complete Hyperbaric Oxygen Therapy and final urine sample collection
次要结局
- Hematuria events(Baseline to 12 months after enrollment)
- Urogenital Distress Inventory (UDI) total score(Baseline to 12 months after enrollment)
- EQ-5D-5L Index Score(Baseline to 12 months after enrollment)
- Completion of Specimen collection(From enrollment until approximately 1 year after enrollment)
研究者
Rachel A. Moses
Principal Investigator
Dartmouth-Hitchcock Medical Center