Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579040
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
The HEROES Trial Hyperbaric Oxygen Therapy for Endometriosis-Related Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The HEROES Trial Hyperbaric Oxygen Therapy for Endometriosis-Related Pain a Prospective Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEROES
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 womans 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
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
Detailed Description:
Endometriosis is caused when endometrial-like tissue is found outside of the uterus It predominantly affects women of reproductive age with an estimated prevalence of 10 worldwide Chronic pain related to endometriosis is one of the primary manifestations that lead individuals to seek treatment with many women reporting moderate to severe pain that can have serious consequences for mental health and quality of life
Current therapeutic approaches for endometriosis include hormonal therapies eg oral contraceptive pills progestins and Gonadotropin-Releasing Hormone agonistsantagonists While these treatments may provide temporary symptom relief they are often associated with serious side effects and preclude conception during treatment The efficacy of other medical interventions remains controversial therefore surgical procedures are often indicated However surgery also has associated risks has long wait times between 6 months and 3 years and a considerable percentage of patients experience recurrence of pain following surgical resection
Pathologically endometriosis is characterized by angiogenesis inflammation and a chronic hypoxic state at the cellular level Because of this Hyperbaric Oxygen Therapy HBOT which suppresses inflammation and promotes tissue healing offers promise as a novel therapeutic modality This is supported by murine models which demonstrate the ability of HBOT to reduce inflammation and inflammatory cytokines in the context of endometriosis in animals However there have not been any human studies investigating the use of HBOT for treatment of endometriosis and related pain
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 standard treatments eg hormonal and non-hormonal medical options is more effective at treating endometriosis pain than the standard treatments alone
Current therapeutic approaches for endometriosis include hormonal therapies eg oral contraceptive pills progestins and Gonadotropin-Releasing Hormone agonistsantagonists While these treatments may provide temporary symptom relief they are often associated with serious side effects and preclude conception during treatment The efficacy of other medical interventions remains controversial therefore surgical procedures are often indicated However surgery also has associated risks has long wait times between 6 months and 3 years and a considerable percentage of patients experience recurrence of pain following surgical resection
Pathologically endometriosis is characterized by angiogenesis inflammation and a chronic hypoxic state at the cellular level Because of this Hyperbaric Oxygen Therapy HBOT which suppresses inflammation and promotes tissue healing offers promise as a novel therapeutic modality This is supported by murine models which demonstrate the ability of HBOT to reduce inflammation and inflammatory cytokines in the context of endometriosis in animals However there have not been any human studies investigating the use of HBOT for treatment of endometriosis and related pain
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 standard treatments eg hormonal and non-hormonal medical options is more effective at treating endometriosis pain than the standard treatments alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None