Effect of Meal Timing During Adjuvant Treatment for Cancer

Summary

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.

Conditions

• Cancer

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Alaska Native Tribal Health Consortium

  collaborator OTHER

• Alaska Native Medical Center

  collaborator OTHER

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Jane Figueiredo, PhD · Cedars-Sinai Medical Center

• Timothy Thomas, MD · Alaska Native Tribal Health Consortium (ANTHC)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2029-08-31

Completion

2029-08-31

Countries

• United States

Study Locations