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
Qualifiers
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
Treatments tested in this trial
- Time-restricted eating
- Questionnaire Administration
- Biospecimen Collection
- Health coaching
Treatment groups
Locations
1Sponsors and collaborators
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