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

Recruiting now · Not applicable

Conditions studied: 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

In brief

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 facts

Study ID: NCT06802172
Run by: Fred Hutchinson Cancer Center
People needed: 100
Starts: 2026-07-23
Expected to finish: 2029-08-31
Last updated by the study team: 2026-07-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female
Self-identify as Alaska Native or American Indian person and eligible for care at the ANMC
Age≥21 years
Histologically confirmed rectal cancer stage II, III, or IV (if curative) per AJCC criteria (neoadjuvant)
Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria (neoadjuvant)
Histologically or cytologically confirmed solid tumor (adjuvant)
BMI≥18.5 kg/m2
Plan to receive neoadjuvant or adjuvant therapy
Planned duration of neoadjuvant or systemic adjuvant therapy for >3 months to allow sufficient time to assess impact of intervention
Must have capacity to give informed consent
Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions
Has completed ≤ 4 weeks of neoadjuvant or adjuvant treatment prior to study enrollment
Score of < 4 on U.S. Household Food Security Survey Module: Six-Item Short Form OR if score >5, have clearance from dietitian

You may not qualify if…

History of cytotoxic chemotherapy ≤12 months prior to rectal or breast cancer diagnosis (neoadjuvant)
Allergic reaction to any of the treatment agents
Any prior pelvic radiotherapy
Active second malignancy (exceptions: non-melanoma skin cancers or cervical carcinoma in situ adequately treated) requiring systemic therapy
History of GI perforation ≤12 months prior to enrollment
History of predisposing colonic or small bowel disorders with severe or rapidly worsening symptoms (not related to current cancer symptoms)
Receiving any parenteral nutrition or enteral (tube) feeding or using similar nutritional supplement during the study period
History of uncontrolled CHF defined as NYHA Class III or greater
Pre-existing grade ≥3 neuropathy
Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment
Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
Pregnant or breastfeeding
Currently perform overnight shift work >1 day/week
Strictly adhering to a <10-hour eating window on most days
Severe psychiatric, cognitive, or substance misuse disorders or social conditions that would interfere with adherence to study procedures.

Where it is running

Alaska Native Medical Center (ANMC) — Anchorage, Alaska, United States (enrolling)

Full record on ClinicalTrials.gov

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