The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain
Recruiting now · Not applicable
Conditions studied: Endometriosis-related Pain
In brief
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.
Key facts
- Study ID
- NCT06579040
- Run by
- Sunnybrook Health Sciences Centre
- People needed
- 64
- Starts
- 2025-04-08
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years old
- Patients having refractory pelvic pain (NRS≥4) secondary to endometriosis for \>6 months
- May or may not be on traditional multi-modal treatment (pharmacological and/or non-pharmacological)
- On waitlist for surgical treatment
You may not qualify if…
- Patients with chronic pain resulting from disease processes unrelated to the pathophysiology of endometriosis-related symptoms (e.g. irritable bowel syndrome, migraine headache, fibromyalgia, chronic low back pain, and musculoskeletal injuries)
- Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (e.g. pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)
- Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)
Where it is running
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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