RecruitingNot ApplicableNCT06802172

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


Sponsor

Fred Hutchinson Cancer Center

Enrollment

100 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether restricting the timing of meals (eating only during a set window of the day) during cancer treatment can improve health outcomes for Alaska Native and American Indian patients receiving chemotherapy for colorectal cancer, breast cancer, or other solid tumors. **You may be eligible if...** - You are 21 or older - You self-identify as Alaska Native or American Indian and receive care at Alaska Native Medical Center - You have been diagnosed with rectal cancer (stage II–IV), HER2+ or triple-negative breast cancer (stage I–III), or another solid tumor - You are planning to receive at least 3 months of chemotherapy (neoadjuvant or adjuvant) - Your BMI is 18.5 or above **You may NOT be eligible if...** - You have a serious eating disorder - You have uncontrolled diabetes - You are pregnant - You are unable to follow a time-restricted eating schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTime-restricted eating

Participate in time-restricted eating plan

OTHERQuestionnaire Administration

Complete questionnaire

PROCEDUREBiospecimen Collection

Undergo collection of blood and stool

BEHAVIORALHealth coaching

Receive nutrition counseling


Locations(1)

Alaska Native Medical Center (ANMC)

Anchorage, Alaska, United States

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NCT06802172


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