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

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06802172
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Time-restricted eating — BEHAVIORAL
    Participate in time-restricted eating plan
  • Questionnaire Administration — OTHER
    Complete questionnaire
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and stool
  • Health coaching — BEHAVIORAL
    Receive nutrition counseling

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Time-restricted eating (TRE)
    Participants assigned to the TRE group will have an 8-hour daily eating period, starting 1-3 hours after waking up \[8 hours eating / 16 hours fasting per day (6+ days a week)\].
  • Active Comparator: Control group
    Participants assigned to the control group are not time-restricted, and have a 12+ hour window of eating per day.

Primary Outcome Measure

Pathological Complete Response (pCR) rate [ Time Frame: At completion of neoadjuvant treatment (3-6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Alaska Native Medical Center (ANMC)AnchorageAlaska99508
Timothy Thomas, MD
[email protected]
(907) 729-3095
Timothy Thomas, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Alaska Native Medical Center (ANMC)· Anchorage, AK

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