About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Time-restricted eating
BehavioralParticipate in time-restricted eating plan
Questionnaire Administration
Other interventionComplete questionnaire
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood and stool
Health coaching
BehavioralReceive nutrition counseling
Treatment groups
Trial outcomes
Primary outcomes
Patient-reported treatment-related toxicities: Average weekly scores
Assessed via Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE v5) toxicities, which is administered weekly throughout intervention and therapy; average scores calculated at each time point, timed to oncologic treatment cycles.
Treatment Delivery: Relative dose intensity (RDI)
Relative dose intensity (RDI), defined as delivered/planned dose intensity, will be analyzed both as a continuous outcome (% of delivered vs planned) and as a binary outcome (≥85% vs. \< 85%). Regimen-level RDI will be calculated as the average across drugs or based on the dose-limiting agent.
Treatment Delivery: Number of patients completing planned adjuvant therapy without unplanned dose reductions or delays
Secondary outcomes
Clinician-reported CTCAE grade ≥3 toxicities
Clinician-reported Toxicity Index
Changes in quality of life (QOL): EORTC QLQ-C30
Change in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), a validated 30-item instrument measuring global health status/quality of life, functional domains (physical, role, emotional, cognitive, and social functioning), and symptom domains. Scores are linearly transformed to a 0-100 scale according to standard scoring guidelines. For global health status and functional scales, higher scores indicate better functioning or quality of life; for symptom scales, higher scores indicate greater symptom burden.
PROMIS Anxiety
Change in anxiety measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form. Scores are standardized T-scores (mean = 50, standard deviation = 10). Higher scores indicate greater anxiety.
Sponsors and contacts
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Fred Hutchinson Cancer Center
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
National Cancer Institute (NCI)
Collaborator
Alaska Native Tribal Health Consortium
Collaborator
Alaska Native Medical Center
Collaborator
Cedars-Sinai Medical Center
Collaborator
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