Lifestyle Intervention for Uterine Fibroids

Recruiting in Palo Alto (17 mi)

Overseen by Taraneh Shirazian, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Approved in 1 Jurisdiction

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{10 11 12 13 14}

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

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.

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.

Treatment Details

Interventions

• LIFE program (Behavioural Intervention)

Trial Overview The 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

Group I: Study group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 116 premenopausal women with uterine leiomyomas, symptoms like pain and bleeding were the main factors influencing the decision to choose surgical intervention, rather than the number or size of the fibroids.

Both black and white women opted for treatment at similar rates (44% and 40%, respectively) when experiencing significant symptoms, indicating that effective management of these symptoms could potentially reduce the need for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fibroid growth study: determinants of therapeutic intervention. Davis, BJ., Haneke, KE., Miner, K., et al.[2021]

The novel uterine fibroid treatment device demonstrated a significant reduction in fibroid volume, with a mean decrease of 36.3% at 3 months and 60.4% at 12 months, indicating its efficacy in treating uterine fibroids.

The study involved 16 symptomatic pre-menopausal black women and showed no serious adverse events or unanticipated risks, suggesting that the device is safe for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids. Tal, MG., Keidar, R., Magnazi, G., et al.[2023]

A systematic review of 52 studies on medical therapies for fibroids highlights the need for uterine-sparing treatments that preserve fertility and avoid surgery, addressing patient demands.

The review identified multiple effective agents that could serve as promising alternatives to surgical options for treating fibroids, indicating potential advancements in medical management of this common condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evidence-based Approach to the Medical Management of Fibroids: A Systematic Review. Bartels, CB., Cayton, KC., Chuong, FS., et al.[2018]

A community-based lifestyle modification program significantly improved remission rates of non-alcoholic fatty liver disease (NAFLD), with 64% of participants achieving remission compared to only 20% in the control group after 12 months.

Participants in the intervention group experienced a mean reduction in liver fat of 6.7% and a weight loss of 5.6 kg, demonstrating that even modest weight loss (3-4.9%) can lead to remission in some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial. Wong, VW., Chan, RS., Wong, GL., et al.[2022]

A 10-week diet plus exercise program significantly improved liver health and overall fitness in patients with nonalcoholic fatty liver disease (NAFLD), showing better results than exercise alone.

While both diet-plus-exercise and exercise-only programs improved health markers like body weight and insulin sensitivity, only the diet-plus-exercise group showed significant improvements in liver biochemistry, highlighting its greater efficacy in treating NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of therapeutic lifestyle program on ultrasound-diagnosed nonalcoholic fatty liver disease. Chen, SM., Liu, CY., Li, SR., et al.[2022]

There is currently no single validated treatment for non-alcoholic fatty liver disease (NAFLD), as its multifactorial nature requires addressing various risk factors through participatory interventions and lifestyle changes.

Participatory medicine, which emphasizes awareness and education about NAFLD, can lead to better prevention and management strategies, utilizing non-invasive imaging and training for healthcare professionals to promote healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Trovato, FM., Catalano, D., Musumeci, G., et al.[2020]

Lifestyle modifications, such as diet and exercise, are crucial for treating non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), but current clinical trials lack a systematic approach to evaluate their impact on treatment outcomes.

The review highlights the need for better methods to assess lifestyle changes in clinical trials, aiming to improve the understanding of how these modifications can influence disease activity and enhance the interpretation of trial results across different phases of research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum. Glass, O., Filozof, C., Noureddin, M., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis. [2020]

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

Risk factors for surgically removed fibroids in a large cohort of teachers. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

The burden of uterine fibroids in five European countries. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Prevalence of uterine fibroids in France and impact on quality of life: results of a survey among 2500 women between 30-55 years]. [2015]

5. Ireland pubmed.ncbi.nlm.nih.gov

Impact of uterine fibroids on quality of life: a national cross-sectional survey. [2019]

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

The fibroid growth study: determinants of therapeutic intervention. [2021]

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

Pressure-Induced Fibroid Ischemia: First-In-Human Experience with a Novel Device for Laparoscopic Treatment of Symptomatic Uterine Fibroids. [2023]

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

The risk of hypertension and cardiovascular disease in women with uterine fibroids. [2021]

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

An Evidence-based Approach to the Medical Management of Fibroids: A Systematic Review. [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Lifestyle interventions for the treatment of non-alcoholic fatty liver disease. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of therapeutic lifestyle program on ultrasound-diagnosed nonalcoholic fatty liver disease. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

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]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum. [2023]