Effect of Meal Timing During Adjuvant Treatment for Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Time-restricted eating, Questionnaire Administration, Biospecimen Collection, Health coaching.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Meal Timing During Adjuvant Treatment for Cancer: A Randomized Clinical Trial
Overview
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.
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.
Interventions
- Behavioral Time-restricted eating
Participate in time-restricted eating plan - Other Questionnaire Administration
Complete questionnaire - Procedure Biospecimen Collection
Undergo collection of blood and stool - Behavioral Health coaching
Receive nutrition counseling
Primary outcome measures
- Patient-reported treatment-related toxicities: Average weekly scores [Time frame: Assessed weekly from start of intervention through end of intervention (up to approximately 6 months)]
- Treatment Delivery: Relative dose intensity (RDI) [Time frame: At end of intervention (at approximately 6 months)]
- Treatment Delivery: Number of patients completing planned adjuvant therapy without unplanned dose reductions or delays [Time frame: At end of intervention (at approximately 6 monhts)]
Secondary outcome measures (12)
- Clinician-reported CTCAE grade ≥3 toxicities [Time frame: Baseline through end of intervention (at approximately 6 months)]
- Clinician-reported Toxicity Index [Time frame: Baseline through end of intervention (at approximately 6 months)]
- Changes in quality of life (QOL): EORTC QLQ-C30 [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- PROMIS Anxiety [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- PROMIS Fatigue [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- PROMIS Physical Function [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- UCLA Loneliness Scale [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Munich Chronotype Questionnaire (MCTQ) [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Appetite Questionnaire [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Dutch Eating Behavior Questionnaire (DEBQ) [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
- Fasting Insulin [Time frame: Baseline (within 28 days prior to initiation of adjuvant therapy), approximately 2-3 months after treatment initiation, end of treatment (within 6 weeks after completion of adjuvant therapy), and follow-up (6-12 months after completion of treatment)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cedars Sinai Medical Center (CSMC) — Los Angeles
Identifiers
NCT: NCT07524218 · RG1126131 · 1P50CA285275-01A1 · FHIRB21058