Recruiting

Hyperbaric Oxygen

Sponsor:

Rachel A. Moses

Code:

NCT07368647

Conditions

Radiation Cystitis

Urinary Tract Infection (Diagnosis)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Hyperbaric Oxygen Therapy

Study Details

Brief summary:

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

Conditions

Radiation Cystitis

Urinary Tract Infection (Diagnosis)

Study ID

NCT07368647

Start date

Apr 4, 2022

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1: RC with HBOT

Participants with radiation cystitis schedule for hyperbaric oxygen therapy

Cohort 2: HBOT Controls

Participants schedule for hyperbaric oxygen therapy without a history of pelvic radiation

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rachel Moses, MD

(603) 650-5091Rachel.A.Moses@hitchcock.org

Amanda Wittemann

(603)653-0654Amanda.L.Wittemann@Hitchcock.org

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Amanda Wittemann

(603) 653-0654Crystallee.J.Salls@Hitchcock.org

Crystallee Salls

(603) 653-0495Crystallee.J.Salls@Hitchcock.org

Principal Investigator:

Rachel Moses, MD

More Information

Sponsor

Rachel A. Moses

Last update posted

Jul 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rachel A. Moses on 2026-07-13.