Back to resultsThe Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer (EFFECT-BC)
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Fasting
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring intermittent fasting
Eligibility Criteria
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
Sites / Locations
- Duke Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intermittent Fasting
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Change in body fat
as measured by mean change in percent body fat between baseline and 6 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04691999
Brief Title
The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer
Acronym
EFFECT-BC
Official Title
EFFECT-BC: The EFFECT of Intermittent Fasting on Body Composition in Women With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The PI is leaving Duke for a position in another state.
Study Start Date
December 2, 2021 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
intermittent fasting
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent Fasting
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intermittent Fasting
Intervention Description
16-18 hour fasting period four times per week
Primary Outcome Measure Information:
Title
Adherence to the intermittent fasting program
Description
as determined by the proportion of fasting days met divided by the total fasting days planned for each participant
Time Frame
6 months
Title
Change in body fat
Description
as measured by mean change in percent body fat between baseline and 6 months
Time Frame
baseline, 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
participant eligibility is not based on self-representation of gender identity
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Champ, MD CSCS
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer
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