Effect of Meal Timing During Adjuvant Treatment for Cancer
Purpose
The goal of this clinical trial is to test meal-timing as a novel and sustainable interventional approach during cancer treatment to improve therapeutic response, patient well-being and long-term metabolic health. In alignment with these priorities, we propose to focus on patients with histologically or cytologically confirmed solid tumors treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care). A promising strategy for improving the efficacy of anticancer treatments and reducing associated toxicities involves combining treatment with fasting regimens. In pre-clinical and clinical studies, various forms of fasting have been shown to induce tumor regression and improve long-term survival. According to the differential stress sensitization theory, fasting is thought to sensitize tumor cells to the cytotoxic effects of chemotherapy and radiation, while protecting healthy cells by increasing stress resistance. While healthy cells slow their growth and become more stress resistant in response to fasting, cancer cells cannot survive in nutrient-deficient environments; although the underlying mechanisms are not fully understood. However, extended water-only fasting can be challenging for patients and poses undue health risks. Intermittent fasting, and specifically time-restricted eating (TRE), may offer a viable alternative. TRE involves eating within a shorter window (e.g., 8 hours) and fasting for the remainder of the day but involves no other dietary restrictions. Because of its simplicity, TRE may be more sustainable than other fasting regimens. TRE also improves several cardio-metabolic endpoints, including insulin sensitivity, which may also be beneficial during anticancer treatments.
Condition
- Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥18 years (no upper age limit) - Any sex or gender - Histologically or cytologically confirmed solid tumor treated with curative-intent surgical resection and planned initiation of systemic adjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation per standard of care) - BMI ≥18.5 kg/m2 - Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
Exclusion Criteria
- No plan for systemic adjuvant therapy after surgery - Strictly adhering to a <10-hour eating window on most days - Regular overnight shift work (≥1 night shift per week) - Dependent on parenteral or enteral nutrition - Pregnant or breastfeeding - Active second malignancy requiring systemic therapy (exceptions: non-melanoma skin cancers or in situ cervical cancers adequately treated) - Severe psychiatric, cognitive, or social conditions that would interfere with adherence to study procedures
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Time-restricted eating (TRE) |
Participants assigned to the TRE group will have an 8-hour daily eating period, starting 1-3 hours after waking up [8 hours eating / 16 hours fasting per day (6+ days a week)]. |
|
|
Active Comparator Control group |
Participants assigned to the control group are not time-restricted, and have a 12+ hour window of eating per day. |
|
Recruiting Locations
Los Angeles, California 90048
More Details
- Status
- Recruiting
- Sponsor
- Fred Hutchinson Cancer Center
Detailed Description
Participants will be randomized to one of two groups: 1. Time-restricted eating (TRE) (8-hour daily eating period, starting 1-3 hours after waking up), OR 2. A control group defined as a ≥12-hour daily eating period. Participants are assigned to either TRE (8-hour daily eating period, starting 1-3 hours after waking up) or a control group defined as a ≥12-hour daily eating period. Their randomized meal assignment arm begins no later than 1-2 week after they begin cancer treatment and ends at end of treatment (resection if indicated). This is a period of approximately 6 months. During this time, participants will be asked to record the time they started and finished eating every day. Electronic reminders and weekly calls to the participants will be made by study staff who maintain records of patient's meal timing. Researchers will time the TRE schedules relative to sleep time (not time of day), which is a reasonable proxy for circadian time. The control group was designed to mimic typical eating habits in the U.S., as data from NHANES suggest that the median American eats over a 12.5-hour period each day. Aside from these general prescriptions, no set number of snacks, meals, or calories will be prescribed. Instead, researchers will measure how TRE affects self-reported mealtimes, meal frequency, and food intake through a combination of daily adherence surveys, 3-day food records and continuous glucose monitoring (CGM). Participants will receive weekly one-on-one nutrition counseling during the first month and then monthly counseling sessions thereafter. Participants will complete questionnaires at intake and subsequent follow-up assessments. Blood and stool samples will also be collected from participants throughout the study.