Lifestyle Intervention for Uterine Fibroids
Trial Summary
What is the purpose of this trial?
This trial is testing a program that includes changes to daily habits, diet, and physical activity for patients who have had fibroid removal surgery. The goal is to see if these changes can help prevent fibroids from coming back.
Do I have to stop taking my current medications for the trial?
The trial excludes participants using medications that affect fibroid growth, like hormonal or GNRH agonists. If you're on such medications, you may need to stop them to participate.
Will I have to stop taking my current medications?
The trial excludes participants using medications that affect fibroid growth, so you may need to stop such medications to join. However, the protocol does not specify about other medications.
What data supports the idea that Lifestyle Intervention for Uterine Fibroids is an effective treatment?
The available research does not provide specific data on the effectiveness of the Lifestyle Intervention for Uterine Fibroids (LIFE program) as a treatment. The studies focus on the prevalence and impact of uterine fibroids on quality of life and work productivity, but they do not include information on the outcomes of the LIFE program or compare it to other treatments. Therefore, there is no direct evidence from the provided research to support the effectiveness of the LIFE program for treating uterine fibroids.12345
What safety data exists for the Lifestyle Intervention for Uterine Fibroids treatment?
The provided research does not directly address the safety data for the Lifestyle Intervention for Uterine Fibroids treatment, also known as the LIFE program or LIFE Study. However, the study titled 'Pressure-Induced Fibroid Ischemia' reports on a novel device for fibroid treatment, indicating no serious safety concerns or unanticipated risks in its initial clinical assessment. This suggests that similar non-surgical interventions may have a favorable safety profile, but specific safety data for the LIFE program is not available in the provided research.16789
Is the Lifestyle Intervention for Uterine Fibroids generally safe for humans?
Is the LIFE program a promising treatment for uterine fibroids?
The LIFE program, which focuses on lifestyle changes like diet and exercise, is promising because similar lifestyle interventions have shown benefits in managing other health conditions like non-alcoholic fatty liver disease. These interventions can improve health by promoting better habits and reducing disease symptoms.1011121314
How does the LIFE program for uterine fibroids differ from other treatments?
The LIFE program is unique because it focuses on lifestyle changes, such as diet and exercise, to manage uterine fibroids, rather than relying on medication or surgery. This approach is similar to treatments for non-alcoholic fatty liver disease, where lifestyle modification is a key strategy.1011121314
Research Team
Taraneh Shirazian, MD
Principal Investigator
NYU Langone Health
Eligibility Criteria
This trial is for English-speaking women aged 18-50 who have recently had fibroid removal surgery at the Center for Fibroid Care at NYU and are now 'fibroid free.' They must have seen their primary care physician in the last three months. Women on certain medications, outside the post-surgery window, postmenopausal, unable to exercise, with dietary restrictions due to GI disorders, or who are pregnant cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Post-surgical Enrollment
Participants are enrolled into a lifestyle, nutrition, supplement, and exercise program post-surgery
Lifestyle Intervention
Participants follow the LIFE program to assess its feasibility and impact on fibroid recurrence
Follow-up
Participants are monitored for changes in fibroid recurrence and quality of life
Treatment Details
Interventions
- LIFE program
LIFE program is already approved in United States for the following indications:
- Prevention of fibroid recurrence
- Management of uterine fibroids
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor