Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers

Обзор

Collection of urine, blood, and tissue samples from patients undergoing hyperbaric oxygen therapy

Вмешательства

• Другое 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.

Первичные конечные точки

• Urinary 8-Hydroxy-2'-deoxyguanosine (8-OHdG) concentration [Срок оценки: Baseline to 12 months post-HBOT]
• Urinary Tumor Necrosis Factor-alpha (TNF-α) concentration [Срок оценки: Baseline to 12 months post-HBOT]
• Urinary Interleukin-6 (IL-6) concentration [Срок оценки: Baseline to 12 months post-HBOT]
• Urinary Vascular Endothelial Growth Factor (VEGF) concentration [Срок оценки: Baseline to 12 months post-HBOT]

Вторичные конечные точки (3)

• Hematuria events [Срок оценки: Baseline to 12 months after enrollment]
• Urogenital Distress Inventory (UDI) total score [Срок оценки: Baseline to 12 months after enrollment]
• EQ-5D-5L Index Score [Срок оценки: Baseline to 12 months after enrollment]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Dartmouth-Hitchcock Medical Center — Lebanon

Идентификаторы

NCT: NCT07368647 · STUDY02001352

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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