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. We want 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.
We know very little about how nutrition therapy can affect breast cancer treatment outcomes. Current standard care suggests enough daily calories and protein to maintain body weight and avoid muscle loss. However, this approach may be antiquated given weight gain is common during treatment and emerging pre-clinical and clinical evidence suggest that fasting during chemotherapy may improve clinical and patient-reported outcomes. For example, preliminary human trials examining the fasting mimicking diet (very low-calorie, low-protein diet 1-week per month) or short-term fasting (48-120 hours (h)), known as periodic fasting, surrounding chemotherapy may increase effectiveness of treatment and decrease side effects related to chemotherapy. Yet these diets have low adherence, side effects of their own, and may increase patient burden and decrease quality of life. In contrast, time restricted eating (TRE) is a form of intermittent fasting with high adherence that may have similar positive effects on treatment outcomes without the untoward side-effects. Moreover, TRE may have beneficial effects on glucose regulation and body composition (i.e., decreased weight and body fat gain) suggesting the potential importance of this regimen to breast cancer recurrence. TRE is extremely accessible with no calorie counting or financial burden to the patient, individuals just shorten their eating window daily. We aim to test the feasibility and acceptability of 24-weeks of 8-h TRE among female breast cancer patients initiating chemotherapy. Additionally we will examine the reliminary effect of 8-h TRE on treatment outcomes, treatment related side-effects, and patient reported quality of life and fatigue. Exploratory outcomes will include glucose regulation, body weight, body composition, IGF-1, IGFBP3, SHBG, estradiol (e2), TNF-alpha, and hsCRP
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Participants 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.
University of Illinois Chicago
Chicago, Illinois, United States
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
Time frame: 24 weeks
TRE Acceptibility
attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored
Time frame: 24 weeks
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.
Time frame: 24 weeks
Quality of Life
QLQ-C30
Time frame: 24 weeks
Fatigue
The Functional assessment of Cancer therapy - fatigue
Time frame: 24 weeks
Treatment related side effects
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, PRO-CTCAE
Time frame: 24 weeks
Safety
CBC
Time frame: 24 weeks
Change in Insulin
Time frame: 24 weeks
Change in glucose
Time frame: 24 weeks
Change in HbA1c
Time frame: 24 weeks
Change in TNF-alpha
Time frame: 24 weeks
Change in body weight
Time frame: 24 weeks
Change in fat mass
Time frame: 24 weeks
Change in lean mass
Time frame: 24 weeks
Change in visceral adiposity
Time frame: 24 weeks
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