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

NCT ID: NCT04691999

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-02

Study Completion Date

2023-08-31

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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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intermittent fasting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intermittent Fasting

Intervention Type BEHAVIORAL

16-18 hour fasting period four times per week

Interventions

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Intermittent Fasting

16-18 hour fasting period four times per week

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colin Champ, MD CSCS

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Duke Cancer Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00107216

Identifier Type: -

Identifier Source: org_study_id