The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer

Study Overview
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Brief Summary
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The objective of this study is to evaluate intermittent fasting after the treatment of breast cancer with surgery and radiation therapy. All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Over six months, the innovative protocol will 1) assess adherence, and is expected to 2) improve body composition, quality of life and inflammatory and metabolic variables linked with outcomes after breast cancer treatment. The long-term goal of this project is to incorporate this dietary strategy as a standard component of care for breast cancer patients.

Official Title
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EFFECT-BC: The EFFECT of Intermittent Fasting on Body Composition in Women With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Intermittent Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast stage I-III completed any chemotherapy prior to initiation of the trial (adjuvant endocrine therapy is permitted) BMI > 25 kg/m2 or body fat% greater or equal to 31% have a schedule amenable to nutrition and dietitian counseling described within the study protocol as determined by the treating radiation oncologist have access to the internet and email with capability to join Zoom calls Exclusion Criteria: Metastatic breast cancer Currently receiving chemotherapy Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, or hemoglobin A1c greater than 8.9. Diabetic condition requiring the usage of insulin

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent Fasting<br>All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. | Behavioral: Intermittent Fasting<br>* 16-18 hour fasting period four times per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the intermittent fasting program | as determined by the proportion of fasting days met divided by the total fasting days planned for each participant | 6 months | 
| Change in body fat | as measured by mean change in percent body fat between baseline and 6 months | baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermittent fasting