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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.
Little is known 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.
The aim of this trial is to examine the feasibility and acceptability of 24-weeks of 8-h TRE among female breast cancer patients initiating chemotherapy. Additionally the preliminary effect of 8-h TRE on treatment outcomes, treatment related side-effects, and patient reported quality of life and fatigue will be explored. Exploratory outcomes will include glucose regulation, body weight, body composition, IGF-1, IGFBP3, SHBG, estradiol (e2), TNF-alpha, and hsCRP
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care control | No Intervention | Participants assigned to standard care will follow the recommendations by American Association for Cancer Research and the American Cancer Society. | |
| 8-h TRE | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted eating | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire | 24 weeks |
| Fatigue | The Functional assessment of Cancer therapy - fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Gabel, RD, PhD | Contact | 312-413-8911 | kdipma2@uic.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center | Recruiting | Chicago | Illinois | 60611 | United States |
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A 24-week open-label controlled trial will be conducted. Forty women with stage I-IV breast cancer initiating chemotherapy will be recruited. Women will be assigned to 8-h TRE (self-selected start at 10am, 11am, or 12pm) ad-libitum eating during a 24-week self-selected 8 hour eating window and fasting 16- hours daily, or standard care for 24 weeks.
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data collectors and sample analysis will be blinded to arm allocation
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| 24 weeks |
| Treatment related side effects | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, PRO-CTCAE | 24 weeks |
| Biochmical blood count Safety | CBC | 24 weeks |
| Change in Insulin | 24 weeks |
| Change in glucose | 24 weeks |
| Change in HbA1c | 24 weeks |
| Change in TNF-alpha | 24 weeks |
| Change in body weight | 24 weeks |
| Change in fat mass | 24 weeks |
| Change in lean mass | 24 weeks |
| Change in visceral adiposity | 24 weeks |
| University of Illinois Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005215 | Fasting |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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