Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

EFFECT-BC intermittent fasting in breast cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an intermittent fasting diet program
is feasible for women with breast cancer and if it can improve weight and body composition after treatment.

What is the Condition Being Studied?

Breast Cancer

Who Can Participate in the Study?

Women ages 20-70 who:
- Have breast cancer stage I-III
- Have a body mass index (BMI) >25
- Are able to attend online (Zoom) counseling sessions (have internet access/email)
- Are not pregnant and have no plans to become pregnant during the study period

Age Group
Adults

What is Involved?

If you join the study, you will have the following tests and procedures done before you start the program and again at the end of the program:
- Physical exams and vital signs
- Non-invasive body composition testing using InBody machine
- Resting metabolic rate measurement by breathing into the MedGem device
- Grip strength measurement using a device that you squeeze in your hand
- Blood draws
- Questionnaires

During the study, you will:
- Intermittently fast for 16-18 hours (skip dinner or breakfast) 4 days per week for 6 months
- Track the fasting days in an online food journal (no calorie counting)
- Participate in online (Zoom) dietary counseling sessions
- Answer questionnaires (online or in person)
- Share medical record information with the research team during the study

Your study participation will last for about 7 months.

Study Details

Full Title
EFFECT-BC: The EFFECT of Intermittent Fasting on Body Composition in Women with Breast Cancer
Principal Investigator
Radiation Oncologist
Protocol Number
IRB: PRO00107216
NCT: NCT04691999
Phase
Phase Pilot
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
More Information
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698