Meal timing during cancer treatment for Alaska Native and American Indian patients
Official title: Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial
Run by Fred Hutchinson Cancer Center · NCT06802172 · Data updated 2026-11-12
This test will see if an 8-hour time-restricted eating schedule during neoadjuvant or adjuvant therapy helps Alaska Native and American Indian adults with rectal or certain breast cancers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fred Hutchinson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Anchorage, Alaska) |
| Status | Recruiting |
| Started | July 23, 2026 |
| Main results expected | August 31, 2029 |
| Study ends | August 31, 2029 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT06802172 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Alaska Native or American Indian adults (≥21 years) with histologically confirmed rectal cancer stage II–IV (with curative intent) or HER2+ or triple-negative breast cancer stage I–III who plan to receive ≥3 months of neoadjuvant or adjuvant therapy and have BMI ≥18.5 kg/m2.
✕Probably not a fit
Patients who are not Alaska Native/American Indian, who do not have the specified cancer types or stages, who cannot adhere to daily meal timing, or who have significant food insecurity or low BMI may be unlikely to benefit from or be eligible for this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with rectal cancer or HER2+ or triple-negative breast cancer who are receiving neoadjuvant or adjuvant therapy at the Alaska Native Medical Center are randomized to follow either an 8-hour daily eating window starting 1–3 hours after waking (time-restricted eating, TRE) or a control ≥12-hour eating window. The randomized intervention begins within 1–2 weeks of treatment start and continues through completion of therapy, a period of approximately six months. Participants record daily meal start and stop times, complete periodic 3-day food records, wear continuous glucose monitors, and receive weekly one-on-one nutrition coaching and adherence reminders. Researchers will compare treatment response, metabolic measures, and adherence between groups to see if TRE improves therapeutic outcomes or reduces treatment-related metabolic harms in this understudied population.
Why it matters
Potential benefit: If effective, TRE could improve cancer treatment response and metabolic health during therapy, potentially reducing side effects and improving outcomes.
How similar studies have gone: Preclinical and some clinical fasting approaches have shown promising effects on tumor sensitivity and metabolic outcomes, but time-restricted eating during cancer therapy—particularly in Alaska Native populations—remains relatively untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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's running
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Alaska Native Medical Center (ANMC)
Anchorage, Alaska, United States Recruiting
Study contacts
- Principal investigator: Timothy Thomas, MD — Alaska Native Tribal Health Consortium (ANTHC)
- Study coordinator: Timothy Thomas, MD
- Email: tkthomas@anthc.org
- Phone: (907) 729-3095
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.