Clinical trial · Interventional
The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer
EFFECT-BC: The EFFECT of Intermittent Fasting on Body Composition in Women With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The PI is leaving Duke for a position in another state.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intermittent Fasting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intermittent Fasting
- 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.
- interventionNames
- Behavioral: Intermittent Fasting
Primary outcomes (2)
- measure
- Adherence to the intermittent fasting program
- timeFrame
- 6 months
- description
- as determined by the proportion of fasting days met divided by the total fasting days planned for each participant
- measure
- Change in body fat
- timeFrame
- baseline, 6 months
- description
- as measured by mean change in percent body fat between baseline and 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available