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

Breast Cancer Clinical Trial

— EFFECT-BC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04691999
• Other study ID #: Pro00107216
• Status: Withdrawn
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: August 2023

Study information

• Verified date: November 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Intermittent Fasting
16-18 hour fasting period four times per week

Locations

Country	Name	City	State
United States	Duke Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in body fat	as measured by mean change in percent body fat between baseline and 6 months	baseline, 6 months