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

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Rachel A. Moses
Study ID
NCT07368647
Status
Recruiting
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Conditions

  • Radiation Cystitis
  • Urinary Tract Infection (Diagnosis)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hyperbaric Oxygen Therapy — OTHER
    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.

Study Details

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

Key Dates

Start date
Apr 4, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Cohort 1: RC with HBOT
    Participants with radiation cystitis schedule for hyperbaric oxygen therapy
  • Arm: Cohort 2: HBOT Controls
    Participants schedule for hyperbaric oxygen therapy without a history of pelvic radiation
  • Arm: Cohort 3: Healthy Controls
    Age and gender matched controls with no history of radiation exposure
  • Arm: Cohort 4: RC with no HBOT
    Participants with radiation cystitis who elect not to undergo hyperbaric oxygen therapy

Primary Outcome Measure

Completion of HBOT [ Time Frame: From enrollment to 1 year after completion of HBOT treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Amanda Wittemann
[email protected]
(603) 653-0654
Crystallee Salls
[email protected]
(603) 653-0495
Rachel Moses, MD (PRINCIPAL_INVESTIGATOR)
Jay Buckey, MD (SUB_INVESTIGATOR)

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By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

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