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The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain

The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain: A Prospective Randomized Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06579040
Acronym
HEROES
Enrollment
64
Registered
2024-08-30
Start date
2025-04-08
Completion date
2027-12-01
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis-related Pain

Keywords

Endometriosis, Endometriosis-related Pain, Hyperbaric Oxygen Therapy, HBOT

Brief 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.

Detailed description

Endometriosis is caused when endometrial-like tissue is found outside of the uterus. It predominantly affects women of reproductive age, with an estimated prevalence of 10% worldwide. Chronic pain related to endometriosis is one of the primary manifestations that lead individuals to seek treatment, with many women reporting moderate to severe pain that can have serious consequences for mental health and quality of life. Current therapeutic approaches for endometriosis include hormonal therapies (e.g. oral contraceptive pills, progestins, and Gonadotropin-Releasing Hormone agonists/antagonists). While these treatments may provide temporary symptom relief, they are often associated with serious side effects and preclude conception during treatment. The efficacy of other medical interventions remains controversial, therefore surgical procedures are often indicated. However, surgery also has associated risks, has long wait times (between 6 months and 3 years), and a considerable percentage of patients experience recurrence of pain following surgical resection. Pathologically, endometriosis is characterized by angiogenesis, inflammation, and a chronic hypoxic state at the cellular level. Because of this, Hyperbaric Oxygen Therapy (HBOT), which suppresses inflammation and promotes tissue healing, offers promise as a novel therapeutic modality. This is supported by murine models, which demonstrate the ability of HBOT to reduce inflammation and inflammatory cytokines in the context of endometriosis in animals. However, there have not been any human studies investigating the use of HBOT for treatment of endometriosis and related pain. This study aims to explore HBOT as a treatment for endometriosis related pelvic pain. Specifically, the investigators will test if HBOT, in addition to the standard treatments (e.g. hormonal and non-hormonal medical options), is more effective at treating endometriosis pain than the standard treatments alone.

Interventions

DEVICEMonoplace Hyperbaric Chamber (Class III medical device)

Participants in the intervention group will be triaged to the closest hyperbaric facility to their address and treated with 40 HBOTs (2 ATM for 90 mins, scheduled daily from Monday to Friday). As HBOT is not a service currently offered at Sunnybrook Hospital, all HBOT treatments will be provided at three collaborating outpatient facilities, Halton Hyperbaric Unit, Restore Hyperbaric Oxygen \& Medical Centre (CPSO-certified Level-II OHP), and Rouge Valley Hyperbaric Medical Centre. All three facilities have the exact same hyperbaric chambers, run by anesthesiologists with advanced training, thus treatments will be identical at all sites.

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

All possible steps will be taken to maintain blinding of the patient's treating physician (i.e., gynecologist) and assessors. The gynecologist will be blinded to the patient's randomization and patients will be instructed not to disclose their allocated group to their gynecologist and/or research assistants.

Intervention model description

Prospective, parallel, randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Change in pain symptoms on the NRSAt baseline, weekly for the first 8 weeks after enrollment, then at 3/4/5/6 month follow upsAssessed on the numeric rating scale between 0 to 10, with 10 indicating the worst possible pain

Secondary

MeasureTime frameDescription
Change in pain frequencyAt baseline, weekly for the first 8 weeks after enrollment, then at 3/4/5/6 month follow upsThe change in pain frequency will be assessed on a 5-point Likert scale, where 1 is "never" and 5 is "always."
Change in opioid consumptionAt baseline, weekly for the first 8 weeks after enrollment, then at 3/4/5/6 monthsCollected as a categorical variable ("Are you taking 1) more, 2) same or 3) less compared to start of treatment?")
Participant Quality of Life on the EHP-30At baseline, and every month for 6 monthsThe 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.
Participant Quality of Life on the SF-36At baseline, and every month for 6 monthsThe Quality of Life Short Form Survey-36 is a widely used tool to assess an individual's overall health-related quality of life.

Countries

Canada

Contacts

CONTACTFahad Alam, MD
fahad.alam@sunnybrook.ca416-480-4864
CONTACTGrace Liu, MD
grace.liu@sunnybrook.ca416-480-6100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026