100 Participants Needed

Lifestyle Intervention for Uterine Fibroids

TS
Overseen ByTaraneh Shirazian, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

The research on a novel device for treating uterine fibroids showed no serious safety concerns or unanticipated risks, suggesting that similar interventions may be safe for humans.16789

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

TS

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

I had surgery to remove fibroids within the last 3 months and am now considered 'fibroid free.'
Visit with PCP within the last 3 months with labs
I can speak, read, and write in English.
See 1 more

Exclusion Criteria

I do not speak English.
I am not on medications that could affect fibroid growth.
I am a woman who has gone through menopause.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-surgical Enrollment

Participants are enrolled into a lifestyle, nutrition, supplement, and exercise program post-surgery

1 month
1 visit (in-person)

Lifestyle Intervention

Participants follow the LIFE program to assess its feasibility and impact on fibroid recurrence

12 months
Surveys collected at 3-6 month intervals

Follow-up

Participants are monitored for changes in fibroid recurrence and quality of life

12 months
Visits at baseline, 6 months, and 12 months

Treatment Details

Interventions

  • LIFE program
Trial OverviewThe LIFE Study is testing a lifestyle intervention program focused on nutrition and exercise. It aims to see if this program can prevent fibroids from coming back by making it part of patients' daily lives. The study will check how well participants accept and stick to this program.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Study groupExperimental Treatment1 Intervention
Healthy patients aged 18-50 who have a uterus, identify as female and have come to the outpatient Center for Women's Health (CWH) for management of bleeding, pelvic pain and fibroids. They will be offered enrollment post-surgery or procedure and will be followed longitudinally for 12 months.

LIFE program is already approved in United States for the following indications:

🇺🇸
Approved in United States as LIFE Program for:
  • Prevention of fibroid recurrence
  • Management of uterine fibroids

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Findings from Research

7.7% of women aged 18-54 in the US reported being diagnosed with uterine fibroids, with prevalence increasing with age and being higher in black women (9.8%) compared to white women (5.4%).
Women with uterine fibroids experienced significantly more severe symptoms, such as heavy menstrual bleeding (16.7% vs 7.7% in those without fibroids) and pelvic pressure (1.6% vs 0.6%), indicating a substantial symptom burden associated with the condition.
Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis.Fuldeore, MJ., Soliman, AM.[2020]
African-American women have the highest risk of developing surgically confirmed fibroids compared to non-Latina white women, highlighting the importance of race in understanding fibroid prevalence.
Postmenopausal women have a lower risk of fibroids than premenopausal women, but hormone replacement therapy increases the risk, suggesting that reproductive factors and hormone treatments play a significant role in fibroid development.
Risk factors for surgically removed fibroids in a large cohort of teachers.Templeman, C., Marshall, SF., Clarke, CA., et al.[2021]
Uterine fibroids (UF) significantly impact health-related quality of life (HRQOL) and work productivity among women in Western Europe, with a mean productivity reduction of 36.1% and general activity impairment of 37.9%.
Many women delay seeking treatment for UF, with 9.0% to 32.5% waiting over five years, indicating a need for increased awareness and encouragement to seek medical help earlier to improve their quality of life.
The burden of uterine fibroids in five European countries.Downes, E., Sikirica, V., Gilabert-Estelles, J., et al.[2022]

References

Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis. [2020]
Risk factors for surgically removed fibroids in a large cohort of teachers. [2021]
The burden of uterine fibroids in five European countries. [2022]
[Prevalence of uterine fibroids in France and impact on quality of life: results of a survey among 2500 women between 30-55 years]. [2015]
Impact of uterine fibroids on quality of life: a national cross-sectional survey. [2019]
The fibroid growth study: determinants of therapeutic intervention. [2021]
Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids. [2023]
The risk of hypertension and cardiovascular disease in women with uterine fibroids. [2021]
An Evidence-based Approach to the Medical Management of Fibroids: A Systematic Review. [2018]
Lifestyle interventions for the treatment of non-alcoholic fatty liver disease. [2021]
Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial. [2022]
Effects of therapeutic lifestyle program on ultrasound-diagnosed nonalcoholic fatty liver disease. [2022]
4Ps medicine of the fatty liver: the research model of predictive, preventive, personalized and participatory medicine-recommendations for facing obesity, fatty liver and fibrosis epidemics. [2020]
Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum. [2023]