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

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Behavioral: Intermittent Fasting

• Registration Number: NCT04691999
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-23
• Study Start: 2021-12-02
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intermittent Fasting	Intermittent Fasting	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Duke Cancer Center; 🇺🇸 Durham, North Carolina, United States