Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial

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 and metabolic health in an understudied population. This clinical trial will enroll patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center (ANMC), which is part of the Alaska Native Tribal Health Consortium (ANTHC).

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

• Rectal Cancer Stage II
• Rectal Cancer Stage III
• Breast Cancer Stage I
• Rectal Cancer Stage IV
• Breast Cancer Stage II
• Breast Cancer Stage III
• Solid Tumor 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

• National Cancer Institute (NCI)

  collaborator NIH

• Alaska Native Tribal Health Consortium

  collaborator OTHER

• Alaska Native Medical Center

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

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

• Jane Figueiredo, PhD, M.Sc. · Cedars-Sinai Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2029-08-31

Completion

2029-08-31

Countries

• United States

Study Locations