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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 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.

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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,656 Total Patients Enrolled
Taraneh Shirazian, MDPrincipal InvestigatorNYU Langone Health

Media Library

LIFE program Clinical Trial Eligibility Overview. Trial Name: NCT05416424 — N/A
Uterine Fibroids Research Study Groups: Study group
Uterine Fibroids Clinical Trial 2023: LIFE program Highlights & Side Effects. Trial Name: NCT05416424 — N/A
LIFE program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05416424 — N/A
~3 spots leftby Dec 2024