The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer (EFFECT-BC)

November 19, 2021 updated by: Duke University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Intermittent Fasting
16-18 hour fasting period four times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the intermittent fasting program
Time Frame: 6 months
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
Time Frame: baseline, 6 months
as measured by mean change in percent body fat between baseline and 6 months
baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Colin Champ, MD CSCS, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 2, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00107216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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