NCT06802172 · Fred Hutchinson Cancer Center
Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Time-restricted eating
Participate in time-restricted eating plan
OTHER
Questionnaire Administration
Complete questionnaire
PROCEDURE
Biospecimen Collection
Undergo collection of blood and stool
BEHAVIORAL
Health coaching
Receive nutrition counseling
Primary outcome measures
Pathological Complete Response (pCR) rate
Time frame: At 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 toxicity
Time frame: From 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Anchorage, Alaska
Collaborators
National Cancer Institute (NCI), Alaska Native Tribal Health Consortium, Alaska Native Medical Center, Cedars-Sinai Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations