The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain
NCT Number: NCT06579040
Acronym: HEROES
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis-related Pain
Interventions: DEVICE: Monoplace Hyperbaric Chamber (Class III medical device)
Sponsor: Sunnybrook Health Sciences Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12
Locations: Sunnybrook Health Sciences Centre, Toronto, Ontario, M4N 3M5, Canada

Summary:
Endometriosis, is a condition where tissue from the uterus, called endometrium, grows outside of the uterus. This effects up to 10% of women, and can lead to long-lasting, moderate to severe pelvic pain, infertility and other symptoms. This can affect a woman's quality of life (including increased risk of depression and anxiety) and is associated with increased healthcare costs.

Current treatments are often limited by serious side effects, and many women resort to surgery. Surgery is also associated with complications and there are long wait times for procedures, sometimes over 3 years. This means that many women continue to suffer from symptoms while they wait for surgery. Therefore, new effective treatments for endometriosis pain are needed.

New research suggests that inflammation and stress caused by lack of oxygen in the affected areas may cause endometriosis. Hyperbaric Oxygen Therapy (HBOT), where patients are placed in a small chamber with higher than normal levels of oxygen, suppresses inflammation and promotes tissue healing. Because inflammation is central to this condition, HBOT has emerged as a potential treatment.

In this study, the investigators will test if HBOT, in addition to the standard treatments, is more effective at treating endometriosis pain than the standard treatments alone.

Primary Outcome Measures: Change in pain symptoms on the NRS, Assessed on the numeric rating scale between 0-10, with 10 indicating the worst possible pain, At baseline, weekly for the first 8 weeks after enrollment, then at 3/4/5/6 months follow ups
Secondary Outcome Measures: Change in opioid consumption, Collected as a categorical variable ("Are you taking 1) more, 2) same or 3) less compared to start of treatment?"), At baseline, weekly for the first 8 weeks after enrollment, then at 3/4/5/6 months|Participant Quality of Life on the EHP-30, The Endometriosis Health Profile-30 is a validated, high-sensitivity, 30-item endometriosis-specific assessment tool for capturing the impact of endometriosis on patient's lives., At baseline, and every month for 6 months|Participant Quality of Life on the SF-36, The Quality of Life Short Form Survey-36 is a widely used tool to assess an individual's overall health-related quality of life., At baseline, and every month for 6 months
Other Outcome Measures: Adherence to HBOT protocol, How many patients complete protocol (minimum 4 treatments per week with \>35 treatments), At 8 weeks (or last session)|Satisfaction assessed by a Patient Satisfaction Questionnaire, Subjective questionnaire completion at end of treatment inquiring about HBOT experience, barriers to and promoters of treatment, At 8 weeks (or last session) and 6 months following enrollment|Cost of study completion, Cost of study completion on a per patient basis including research support, healthcare resource costs, and patient-related personal costs (transport, time from work), Throughout study completion, an average of 6 months