What side effects are associated with this type of intervention?

Common treatments for uterine fibroids include medication, surgical options, and lifestyle modifications. Medications such as hormonal treatments (e.g., oral contraceptives) can cause side effects like nausea, weight gain, and mood changes. Surgical options like myomectomy may lead to risks such as infection, bleeding, and recurrence of fibroids. Lifestyle, nutrition, and exercise modifications, similar to those studied in the LIFE Program, generally have fewer side effects but may require significant lifestyle changes and adherence to be effective. These modifications are typically safe and can improve overall health, though they may not be as immediately effective in reducing fibroid size or symptoms as other treatments.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of uterine fibroids that focus on lifestyle, nutrition, and exercise modifications. However, it does reference various medical and surgical treatments for uterine fibroids, such as mifepristone, which has been studied for its effects on reducing fibroid size and improving symptoms. The LIFE Program, which is being studied for its potential to modify fibroid recurrence through lifestyle interventions, represents a different approach that is not yet detailed in terms of FDA approval.

What other types of research exist?

Promising alternatives to the LIFE Program for uterine fibroids patients include: 1) Uterine artery embolization (UAE), which reduces fibroid size by cutting off their blood supply; 2) MRI-guided focused ultrasound surgery (MRgFUS), a non-invasive procedure that uses high-intensity ultrasound waves to destroy fibroids; 3) New pharmacological treatments such as selective progesterone receptor modulators (SPRMs) and oral GnRH antagonists, which can shrink fibroids and alleviate symptoms; and 4) Minimally invasive surgical options like laparoscopic or robotic myomectomy, which offer quicker recovery times compared to open surgery.

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Lifestyle Intervention for Uterine Fibroids

N/A

Recruiting

Led By Taraneh Shirazian, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who have had a procedure or surgery performed to remove fibroids within the last 3 months and are now considered 'fibroid free.'

Be English speaking and be able to read/write in English

Must not have

Non-English speaking

Postmenopausal women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 month, 12 month

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves lifestyle changes rather than medication, side effects may include typical reactions to new diet or exercise routines such as muscle soreness or digestive adjustments. However, no medical side effects like those from drugs are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had surgery to remove fibroids within the last 3 months and am now considered 'fibroid free.'

Select...

I can speak, read, and write in English.

Select...

I am between 18 and 50 years old and seeking care at the NYU Center for Fibroid Care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English.

Select...

I am a woman who has gone through menopause.

Select...

I am unable to follow a physical activity plan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 month, 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 month, 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 month, 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of LIFE program as measured by Self report survey

Change in fibroid recurrence as measured by standard of care ultrasounds

Change in improvement in quality of life as measured by Quality of Life Scale (QOLS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for uterine fibroids include medical therapy, surgical intervention, and lifestyle modifications. Medical therapies often involve hormonal treatments like GnRH agonists, which reduce estrogen and progesterone levels, leading to a decrease in fibroid size. Surgical options, such as myomectomy, physically remove fibroids but carry risks of complications and recurrence. The LIFE Program focuses on lifestyle, nutrition, and exercise modifications, which aim to manage symptoms and potentially reduce fibroid growth by improving overall health and reducing inflammation. These non-invasive approaches are crucial for patients seeking to avoid surgery and manage fibroid symptoms through sustainable, long-term health improvements.

Evaluation of pharmacological interventions in the management of adenomyosis: a systematic review.Identification of TRADD as a potential biomarker in human uterine leiomyoma through iTRAQ based proteomic profiling.Contraceptive applications of progesterone receptor modulators.