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

NCT06802172 | Recruiting DMC

• 3 other identifiers: RG11244861P50CA285275-01A12111923-7
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Time-restricted eating; Time restricted eating; Meal timing

Outcome Measures

Primary Outcomes (3)

• Pathological Complete Response (pCR) rate

  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.

  At completion of neoadjuvant treatment (3-6 months)

• Treatment-related toxicity

  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.

  From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)

• Treatment Delivery (RDI and Completion)

  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.

  From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)

Secondary Outcomes (10)

• Clinical Complete Response (cCR)

  At completion of neoadjuvant treatment (3-6 months)

• Tumor volume

  From baseline to surgery (3-6 months)

• Objective response rate (ORR)

  At the time of surgery following neoadjuvant treatment completion (3-6 months)

• Neoadjuvant rectal (NAR) score

  At completion of neoadjuvant treatment for rectal cancer (3-6 months)

• Provider-reported adverse events

  From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months)

Study Arms (2)

Time-restricted eating (TRE)

EXPERIMENTAL

Participants assigned to the TRE group will have an 8-hour daily eating period, starting 1-3 hours after waking up \[8 hours eating / 16 hours fasting per day (6+ days a week)\].

Behavioral: Time-restricted eating; Other: Questionnaire Administration; Procedure: Biospecimen Collection; Behavioral: Health coaching

Control group

ACTIVE COMPARATOR

Participants assigned to the control group are not time-restricted, and have a 12+ hour window of eating per day.

Other: Questionnaire Administration; Procedure: Biospecimen Collection; Behavioral: Health coaching

Interventions

Time-restricted eating BEHAVIORAL

Participate in time-restricted eating plan

Time-restricted eating (TRE)

Questionnaire Administration OTHER

Complete questionnaire

Control group; Time-restricted eating (TRE)

Biospecimen Collection PROCEDURE

Undergo collection of blood and stool

Control group; Time-restricted eating (TRE)

Health coaching BEHAVIORAL

Receive nutrition counseling

Control group; Time-restricted eating (TRE)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Alaska Native Tribal Health Consortium: collaborator
• Alaska Native Medical Center: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Alaska Native Medical Center (ANMC)

Anchorage, Alaska, 99508, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Breast Neoplasms; Intermittent Fasting

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Timothy Thomas, MD

  Alaska Native Tribal Health Consortium (ANTHC)

  PRINCIPAL INVESTIGATOR

• Jane Figueiredo, PhD, M.Sc.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Thomas, MD

CONTACT

(907) 729-3095; tkthomas@anthc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research Services

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)