Hyperbaric Oxygen Therapy for Endometriosis

(HEROES Trial)

Overseen By Grace Liu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Irritable bowel syndrome, Migraine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 40

Duration: 8 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that participants may or may not be on traditional treatments, so it seems you can continue your current medications.

How does hyperbaric oxygen therapy differ from other treatments for endometriosis?

Hyperbaric oxygen therapy is unique because it involves breathing pure oxygen in a pressurized room, which is different from the hormone-based or surgical treatments typically used for endometriosis. This therapy may help reduce inflammation and promote healing, offering a novel approach compared to traditional methods that focus on hormone suppression or surgical removal of endometriosis tissue. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I have had surgery for endometriosis in the past.

I may be receiving various treatments for my condition.

Exclusion Criteria

I am medically fit for hyperbaric treatments and do not have conditions like pneumothorax or unstable heart disease.

Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)

I have chronic pain not related to endometriosis, like IBS or fibromyalgia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard multi-modal therapy with or without 40 HBOT treatments (2 ATM for 90 mins daily, 5 days a week)

8 weeks

40 visits (in-person for HBOT)

Follow-up

Participants are monitored for changes in pain symptoms, opioid consumption, and quality of life

6 months

Monthly assessments

Treatment Details

Interventions

• Hyperbaric Oxygen Therapy

Trial Overview 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.

Participant Groups

Group I: Group II (Intervention) Experimental Treatment 1 Intervention

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

Group II: Group I (Control) Active Control 1 Intervention

Standard multi-modal therapy

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Findings from Research

Laparoscopy is the essential surgical method for treating ovarian endometriomas, with cystectomy being the preferred technique, although it can impact normal ovarian tissue.

Postoperative medical treatment is crucial for reducing recurrence rates, especially for patients not seeking to conceive, highlighting the importance of a multidisciplinary approach in management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgery for the management of ovarian endometriomas: from the physiopathology to the pre-, peri- and postoperative treatment]. Bourdel, N., Roman, H., Mage, G., et al.[2011]

Hormone-based medical therapies for endometriosis are highly effective, providing 80%-100% relief from pelvic pain within six months, with serious side effects being rare.

There is a lack of direct comparative studies between medical and surgical treatments for endometriosis, making it difficult for practitioners to determine the best surgical approach due to underreported complications and variability in surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical and surgical therapies for pain associated with endometriosis. Winkel, CA., Scialli, AR.[2013]

Endometriosis can rarely affect the urinary system, particularly the bladder, and is often diagnosed late due to its asymptomatic nature and low occurrence rate (1-2%).

Surgical intervention is recommended for extensive cases of urinary endometriosis, with laparoscopic techniques being the preferred methods for bladder and ureteral resection, depending on the extent of the growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Endometriosis of the ureter and urinary bladder]. Zugor, V., Krot, D., Rösch, WH., et al.[2018]

A small randomized controlled trial indicated that using a hormone-releasing intrauterine system (LNG-IUS) after surgery for endometriosis significantly reduces the recurrence of painful periods compared to a gonadotrophin-releasing hormone (GnRH) agonist.

While women using the LNG-IUS reported higher satisfaction with their treatment, this difference was not statistically significant, highlighting the need for more comprehensive studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levonorgestrel-releasing intrauterine device (LNG-IUD) for symptomatic endometriosis following surgery. Abou-Setta, AM., Al-Inany, HG., Farquhar, CM.[2018]

Surgical treatment for endometriosis, aided by narrow band imaging, is effective for pain relief and improving fertility, although it may not provide a complete cure.

Medical treatments, such as aromatase inhibitors and tubal flushing with lipiodol, can enhance fertility, while lifestyle changes and environmental factors may also play a role in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential cures for endometriosis. Jacobson, TZ.[2011]

References

1. France pubmed.ncbi.nlm.nih.gov

[Surgery for the management of ovarian endometriomas: from the physiopathology to the pre-, peri- and postoperative treatment]. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Medical and surgical therapies for pain associated with endometriosis. [2013]

3. Germany pubmed.ncbi.nlm.nih.gov

[Endometriosis of the ureter and urinary bladder]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Levonorgestrel-releasing intrauterine device (LNG-IUD) for symptomatic endometriosis following surgery. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Potential cures for endometriosis. [2011]