Effect of Meal Timing During Adjuvant Treatment for Cancer

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

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

50 Participants
are divided into 2 treatment groups

Sponsors 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