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Meal Timing During Cancer Treatment for Rectal or Breast Cancer in Alaska

This study is looking at how the timing of your meals might affect cancer treatment for people with Stage I-IV rectal or breast cancer (specifically HER2+ or triple-negative breast cancer) who are receiving care at the Alaska Native Medical Center. You would be randomly assigned to either an 8-hour daily eating period (time-restricted eating) or a typical eating period of 12 hours or more. Researchers will look at how well your cancer responds to treatment, any side effects you experience, and how well you complete your treatment. The study aims to enroll 100 participants.

Study design
This is an interventional study that will randomly assign 100 participants to one of two groups: time-restricted eating or a control group with typical eating habits.
What's involved
You would follow a specific eating schedule for about 6 months, record your eating times daily, complete questionnaires, and provide blood and stool samples. You would also receive nutrition counseling.
Compensation
Not stated in the trial record.
Follow-up
Your treatment-related toxicity and treatment delivery will be measured from enrollment until the completion of your neoadjuvant or adjuvant treatment (3-8 months).

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NCT06802172

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

Recruiting
NAAges 21+Interventional
Fred Hutchinson Cancer Center
~100 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Time-restricted eatingQuestionnaire AdministrationBiospecimen CollectionHealth coaching

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathological Complete Response (pCR) rate
Measured over At completion of neoadjuvant treatment (3-6 months)
+2 more outcomes measured

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

Explore related trials

Breast CarcinomaRectal CarcinomaSolid NeoplasmERBB2 Gene

Where it's being run

1 sites across 1 states
Alaska1

Study leadership

  • Timothy Thomas, MD · PRINCIPAL_INVESTIGATOR · Alaska Native Tribal Health Consortium (ANTHC)
  • Jane Figueiredo, PhD, M.Sc. · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Timothy Thomas, MD
[email protected]
(907) 729-3095
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pathological Complete Response (pCR) rateAt completion of neoadjuvant treatment (3-6 months)

    The pCR will be defined as an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected rectal or breast specimen and all sampled regional lymph nodes. It will be treated as a binary variable.

  • Treatment-related toxicityFrom enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)

    The Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE v.5) measurement system will be used to measure treatment-related toxicities. The PRO-CTCAE will be administered on a weekly basis throughout the intervention and will calculate the average over all items for each time point. Surveys will be timed relative to the start of each oncologic treatment segment.

  • Treatment Delivery (RDI and Completion)From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)

    Chemotherapy, targeted therapy, immunotherapy and/or radiation data will be abstracted to calculate relative dose intensity (RDI--delivered ÷ planned dose intensity, mg/m²/week) for each drug, expressed continuously and dichotomized at ≥85%. Regimen-level RDI will be calculated as the average across drugs or based on the dose-limiting agent. We will also calculate the proportion of participants completing all planned cycles without unplanned reductions or delays.