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

NCT06579040 | Recruiting

• 1 other identifier: 6201
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis-related Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in pain symptoms on the NRS

  Assessed on the numeric rating scale between 0 to 10, with 10 indicating the worst possible pain

  At baseline, weekly for the first 8 weeks after enrollment, then at 3/4/5/6 month follow ups

Secondary Outcomes (4)

• Change in pain frequency

  At baseline, weekly for the first 8 weeks after enrollment, then at 3/4/5/6 month follow ups

• Change in opioid consumption

  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

  At baseline, and every month for 6 months

• Participant Quality of Life on the SF-36

  At baseline, and every month for 6 months

Other Outcomes (3)

• Adherence to HBOT protocol

  At 8 weeks (or last session)

• Satisfaction assessed by a Patient Satisfaction Questionnaire

  At 8 weeks (or last session) and 6 months following enrollment

• Cost of study completion

  Throughout study completion, an average of 6 months

Study Arms (2)

Group I (Control)

NO INTERVENTION

Standard multi-modal therapy

Group II (Intervention)

EXPERIMENTAL

Standard multi-modal therapy + 40 HBOT treatments (2 ATM for 90 mins daily, 5 days a week)

Device: Monoplace Hyperbaric Chamber (Class III medical device)

Interventions

Monoplace Hyperbaric Chamber (Class III medical device) 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.

Group II (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Fahad Alam, MD

CONTACT

416-480-4864; fahad.alam@sunnybrook.ca

Grace Liu, MD

CONTACT

416-480-6100; grace.liu@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, parallel, randomized controlled trial

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 30, 2024
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available following publication of the full trial results.
• Access Criteria: Data and supporting information will be made available following reasonable request directly to study PI.

Locations

CA (1)