Status:
COMPLETED
Prolonged Nightly Fasting in Breast Cancer Survivors
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Kully Family Foundation
Conditions:
Fasting
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is being done to examine whether fasting for 13 hours every night is feasible and if it can help breast cancer survivors lose weight and improve their health. * Previous studies have found...
Detailed Description
This research study involves fasting (not eating any food or drinking fluids that contain calories) for 13 hours nightly for 12 weeks. * It is expected that about 40 people will take part in this res...
Eligibility Criteria
Inclusion
- Participants must have a documented history of histologically confirmed invasive breast cancer.
- Participants with a history of stage I to III invasive breast cancer, and no current evidence of disease.
- A history of bilateral breast cancer is allowed provided the patient is currently disease free, with stage I to III disease on both sides.
- No evidence of distant metastatic disease or unresectable locally recurrent disease
- All adjuvant or neoadjuvant cytotoxic chemotherapy, radiation, and surgery for breast cancer must have been completed at least 6 month prior to registration. Except:
- Adjuvant hormonal therapy is permitted. Must have been on for a minimum of 1 month.
- Adjuvant trastuzumab, pertuzumab, TDM1, or neratinib for Her2 positive breast cancer is permitted Age ≥18 years.
- Participant must be female.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Distant metastatic breast cancer (Stage IV breast cancer) or unresectable locally recurrent disease
- Participants with diabetes mellitus.
- Participants with a pre-existing eating disorder (anorexia nervosa, bulimia)
- Participants with a BMI\< 19kg/m2 or a weight loss of 5% in the last month or 10% in the last 3 months.
- Participants using weight loss medications at the time of study enrollment.
- Participants using oral steroids at the time of enrollment.
- Participants who are receiving any other investigational agents. Participants with uncontrolled intercurrent illness.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the effects of prolonged fasting on the fetus are not known.
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04330339
Start Date
July 24 2020
End Date
July 5 2022
Last Update
July 21 2022
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114