About this trial
This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer. We will test 3 different eating window options compared to a control group for 24 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 25-99 at time of consent
English language or Spanish language (based on availability of lab interpreters)
ECOG 0 or 1
Breast cancer to meet histologically confirmed Stage I-III or Stage IV with Medical Oncology approval.
Disqualifiers
Women with type 1 or insulin dependent type 2 diabetes
Women with BMI > 45kg/m2 and < 18.5 kg/m2
Women who are pregnant or nursing. A negative serum or urine pregnancy test is required per institutional practice guidelines.
Shift workers
Trial design
Parallel
Treatments tested in this trial
Time restricted eating
BehavioralParticipants assigned to this arm will follow the 8-h TRE protocol. Participants will consume food ad libitum (no calorie or food restrictions) during a self-selected 8-h eating window (beginning at 10:00 am, 11:00am, or 12:00 pm) and fasting for 16 hours daily. They will follow this same eating pattern for the length of the intervention. Calorie free drinks such as water, black coffee, and diet soda, are permitted during the fasting period. The eating window will allow for a typical breakfast/lunch/dinner eating pattern.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment feasibility
women eligible and referred by staff to the research team. We will also track the number of referred women approached (by phone \& in person) by our research team for screening/enrollment and the number of women who decline and their reasons for non-enrollment
TRE Acceptibility
attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored
TRE adherence
Diet adherence will be monitored either by patient reported start and stop times of food intake and diet pattern scoring and will be assessed by the study coordinator with a total score of 7 days per week followed by a post intervention qualitative survey.
Secondary outcomes
Quality of Life
European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire
Fatigue
The Functional assessment of Cancer therapy - fatigue
Treatment related side effects
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, PRO-CTCAE
Biochmical blood count Safety
CBC
Sponsors and contacts
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