4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity (NCT06399276) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
4:3 Intermittent Fasting Intervention in Adults With Breast Cancer and Overweight or Obesity
United States36 participantsStarted 2024-05-28
Plain-language summary
This is a 3 month single arm pilot and feasibility study designed to examine the impact of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical milestones (change in body weight, adherence to the fasting program, and moderate-to vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer after they have completed their cancer treatment. The investigators will also evaluate feasibility of recruitment and retention of study participants, safety of the intervention, and obtain feedback from participants to improve the program. Participants will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm (3 modified fast days per week) and support to increase physical activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3 month intervention (primary endpoint) and after a 3 month weight maintenance follow up phase.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Age 18-65 years
* Body Mass Index 25-45 kg/m2
* Diagnosis of stage 1-3 breast cancer within the past 10 years with completion of standard of care definitive surgery, adjuvant chemotherapy, radiation, immunotherapy and/or targeted therapy as appropriate prior to the intervention start date. Completion of definitive surgery must be ≥ 3 months prior to the intervention start date, other therapies must be completed ≥ 1 month prior to the intervention start date (however exceptions to this 1-month timeframe for completion of other therapies can be made on a case-by-case basis by the PI if patients are tolerating therapy without adverse effects and will have completed treatment prior to the intervention start date). Current/ongoing use of anti-endocrine directed therapy for breast cancer (including ovarian suppression, tamoxifen, aromatase inhibitors, selective estrogen degraders) is acceptable as long as participants have been on therapy for ≥3 months prior to the intervention start date.
* Live or work within 30 miles of the AHWC (exceptions may be made at the discretion of the Study PI on a case-by-case basis for highly motivated subjects).
* Capable and willing to give informed consent and understand exclusion criteria, willing to attend weekly small group sessions held by a registered dietitian, and attend one in person BfitBwell exercise sessions per week.
* Have a …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body Weight
Timeframe: 3 months
2
Adherence to 4:3 Intermittent Fasting Dietary Paradigm as Measured by Food Records