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

NCT04691999 | Withdrawn

• 1 other identifier: Pro00107216
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

intermittent fasting

Outcome Measures

Primary Outcomes (2)

• 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

• Change in body fat

  as measured by mean change in percent body fat between baseline and 6 months

  baseline, 6 months

Study Arms (1)

Intermittent Fasting

EXPERIMENTAL

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

Interventions

Intermittent Fasting BEHAVIORAL

16-18 hour fasting period four times per week

Intermittent Fasting

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: participant eligibility is not based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Intermittent Fasting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Colin Champ, MD CSCS

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 31, 2020
• Study Start: December 2, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)