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Hyperbaric Oxygen Therapy 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 with past surgical management for endometriosis
Must not have
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)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 weeks (or last session) and 6 months following enrollment
Awards & highlights
No Placebo-Only Group

Summary

"This trial will test if adding Hyperbaric Oxygen Therapy (HBOT) to standard treatments is more effective in treating endometriosis pain than standard treatments alone. Endometriosis is a condition

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
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I am 18 years old or older.
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I have had surgery for endometriosis in the past.
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I am on a waitlist for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am medically fit for hyperbaric treatments and do not have conditions like pneumothorax or unstable heart disease.
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I have chronic pain not related to endometriosis, like IBS or fibromyalgia.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,791 Total Patients Enrolled
~43 spots leftby Dec 2026
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