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Group II (Intervention) for Endometriosis (HEROES Trial)

N/A
Waitlist Available
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age ≥ 18 years old
* Patients having refractory pelvic pain (NRS≥4) secondary to endometriosis for \>6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 weeks (or last session)
Awards & highlights

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.

Who is the study for?
The HEROES Trial is for women suffering from endometriosis, a condition causing pelvic pain and infertility due to tissue growth outside the uterus. Participants should be seeking additional treatment beyond standard options, which may have limited effectiveness or long wait times for surgery.
What is being tested?
This trial investigates whether Hyperbaric Oxygen Therapy (HBOT), involving breathing pure oxygen in a pressurized chamber, can more effectively reduce endometriosis-related pain when combined with standard treatments compared to standard treatments alone.
What are the potential side effects?
Potential side effects of HBOT include ear pressure changes leading to discomfort or temporary hearing loss, fatigue after sessions, and in rare cases, oxygen toxicity which could cause lung issues or seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 weeks (or last session) and 6 months following enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 8 weeks (or last session) and 6 months following enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in pain symptoms on the NRS
Secondary study objectives
Change in opioid consumption
Participant Quality of Life on the EHP-30
Participant Quality of Life on the SF-36
Other study objectives
Adherence to HBOT protocol
Cost of study completion
Satisfaction assessed by a Patient Satisfaction Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (Intervention)Experimental Treatment1 Intervention
Standard multi-modal therapy + 40 HBOT treatments (2.4 ATM for 90 mins daily, 5 days a week)
Group II: Group I (Control)Active Control1 Intervention
Standard multi-modal therapy

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
662 Previous Clinical Trials
1,554,051 Total Patients Enrolled
~43 spots leftby Dec 2026