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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding Hyperbaric Oxygen Therapy (HBOT) can relieve pain from endometriosis more effectively than usual treatments alone. Endometriosis occurs when tissue from the uterus grows outside its normal location, causing pain and other issues. HBOT involves breathing pure oxygen in a special chamber to reduce inflammation. Women who have experienced pelvic pain from endometriosis for more than six months and are awaiting surgery might be suitable candidates for this trial. The study compares standard treatment to standard treatment plus HBOT. As an unphased trial, it offers a unique opportunity to explore innovative pain relief options beyond standard treatments.

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.

What prior data suggests that Hyperbaric Oxygen Therapy is safe for treating endometriosis?

Research has shown that Hyperbaric Oxygen Therapy (HBOT) is generally well-tolerated by patients. Studies have used it to treat various conditions with few side effects. For instance, one study found that patients using HBOT experienced less pain and improved quality of life. Another study reported improvements in pelvic health without any serious side effects.

HBOT involves breathing pure oxygen in a pressurized chamber and has already received approval for other conditions, indicating a certain level of safety. However, like any treatment, it may carry risks, such as ear discomfort or temporary vision changes. Discuss potential risks with the trial team or your healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperbaric oxygen therapy (HBOT) for endometriosis because it offers a novel approach compared to traditional treatments like hormonal therapy and surgery. Unlike these standard options, HBOT involves breathing pure oxygen in a pressurized chamber, which could reduce inflammation and promote healing by increasing oxygen delivery to affected tissues. This unique mechanism may provide relief more quickly and with fewer side effects than conventional treatments, offering new hope for those struggling with this painful condition.

What evidence suggests that Hyperbaric Oxygen Therapy might be an effective treatment for endometriosis?

This trial will compare the effects of standard multi-modal therapy alone with standard multi-modal therapy plus hyperbaric oxygen therapy (HBOT) for endometriosis. Studies have shown that HBOT can help reduce inflammation, a major factor in endometriosis. In animal studies, HBOT significantly lowered inflammation in tissues affected by endometriosis. This is important because inflammation in the uterus can cause pain and other symptoms. Research also suggests that HBOT can improve tissue health by increasing oxygen supply, potentially aiding in healing and reducing pain. While researchers continue to study HBOT for endometriosis, these findings suggest it might help manage the condition by reducing inflammation and promoting healing. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 have had surgery for endometriosis in the past.

I may be receiving various treatments for my condition.

I have had severe pelvic pain from endometriosis for more than 6 months.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10472734/

Hyperbaric oxygen therapy: a possible choice for patients with ... After a period of HBOT, observations of increased endometrial thickness and improved endometrial quality were reported, along with a live birth ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06579040

The HEROES Trial: Hyperbaric Oxygen Therapy for ... 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 ...

3. clinicaltrial.be clinicaltrial.be/en/details/449074?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Hyperbaric Oxygen Therapy for Endometri... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9334893/

The effect of hyperbaric oxygen therapy in the inflammatory ... HBOT significantly reduced the inflammation level on the endometrial lesion in mice, involving the NF κ B pathway.

5. ctv.veeva.com ctv.veeva.com/study/the-heroes-trial-hyperbaric-oxygen-therapy-for-endometriosis-related-pain

Hyperbaric Oxygen Therapy for Endometriosis-Related Pain 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 ...

6. gynecologiconcologyinstitute.org gynecologiconcologyinstitute.org/news/endometriosis/endometriosis-research/hyperbaric-oxygen-treatment-endometriosis/

Breathing New Life Into Endometriosis Treatment: Hyperbaric ... The study found that HBOT significantly reduced pain and improved quality of life in the participants, as measured by standardized ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0936655507009284

Improved Quality of Life with Hyperbaric Oxygen Therapy ... The scores showed a significant improvement after HBOT (P = 0.001; exact Wilcoxon signed-rank test). Rectal bleeding ceased in five of six patients with ...

8. oxygens.co.uk oxygens.co.uk/hyperbaric-oxygen-therapy-hbot-for-endometriosis-a-breakthrough-in-healing/?srsltid=AfmBOoq1MslC59Igy8RUtnbabSnHA-PSuJKvCeKaw6Hgkt9efrXrFbYV

Hyperbaric Oxygen Therapy (HBOT) For Endometriosis This enhanced oxygenation may help repair the damage caused by endometrial lesions and adhesions, improving overall pelvic health. Promotion of Tissue Healing ...