Modified Title Project 4: Effect of Meal Timing During Cancer Treatment in Alaska Native Patients

NCT ID: NCT06802172

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-08-31

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.

Detailed Description

Participants will be randomized to one of two groups:

1. Time-restricted eating (TRE) (8-hour daily eating period, starting 1-3 hours after waking up), OR

2. A control group defined as a ≥12-hour daily eating period.

Participants are assigned to either TRE (8-hour daily eating period, starting 1-3 hours after waking up) or a control group defined as a ≥12-hour daily eating period. Their randomized meal assignment arm begins no later than 1-2 week after they begin cancer treatment and ends at end of treatment (resection if indicated). This is a period of approximately 6 months.

During this time, participants will be asked to record the time they started and finished eating every day. Electronic reminders and weekly calls to the participants will be made by study staff who maintain records of patient's meal timing. Researchers will time the TRE schedules relative to sleep time (not time of day), which is a reasonable proxy for circadian time. The control group was designed to mimic typical eating habits in the U.S., as data from NHANES suggest that the median American eats over a 12.5-hour period each day. Aside from these general prescriptions, no set number of snacks, meals, or calories will be prescribed. Instead, researchers will measure how TRE affects self-reported mealtimes, meal frequency, and food intake through a combination of daily adherence surveys, 3-day food records and continuous glucose monitoring (CGM).

Participants will receive weekly one-on-one nutrition counseling during the first month and then monthly counseling sessions thereafter. Participants will complete questionnaires at intake and subsequent follow-up assessments. Blood and stool samples will also be collected from participants throughout the study.

Conditions

Rectal Cancer Stage II; Rectal Cancer Stage III; Breast Cancer Stage I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Time-restricted eating (TRE)

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

Group Type: EXPERIMENTAL

Time-restricted eating

Intervention Type: BEHAVIORAL

Participate in time-restricted eating plan

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaire

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood and stool

Health coaching

Intervention Type: BEHAVIORAL

Receive nutrition counseling

Control group

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

Group Type: ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaire

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood and stool

Health coaching

Intervention Type: BEHAVIORAL

Receive nutrition counseling

Interventions

Time-restricted eating

Participate in time-restricted eating plan

Intervention Type: BEHAVIORAL

Questionnaire Administration

Complete questionnaire

Intervention Type: OTHER

Biospecimen Collection

Undergo collection of blood and stool

Intervention Type: PROCEDURE

Health coaching

Receive nutrition counseling

Intervention Type: BEHAVIORAL

Eligibility 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
• Histologically confirmed HER2+ or triple negative breast cancer stage I, II, or III, per AJCC criteria
• BMI≥18.5 kg/m2
• Plan to receive neoadjuvant therapy
• 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 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
• Allergic reaction to any of the treatment agents
• Any prior pelvic radiotherapy
• Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ
• 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 more than one day/week on average Strictly adhering to a <10-hour eating window on most days
• Known psychiatric or substance misuse disorders that would interfere with adhering to the requirements of the trial

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alaska Native Tribal Health Consortium

OTHER

Sponsor Role: collaborator

Alaska Native Medical Center

OTHER

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Timothy Thomas, MD

Director, Research Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Alaska Native Tribal Health Consortium (ANTHC)

Jane Figueiredo, PhD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Alaska Native Medical Center (ANMC)

Anchorage, Alaska, United States

Countries

United States

Central Contacts

Timothy Thomas, MD

Role: CONTACT

tkthomas@anthc.org

(907) 729-3095

Facility Contacts

Timothy Thomas, MD

Role: primary

tkthomas@anthc.org

(907) 729-3095

Other Identifiers

1P50CA285275-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2111923-7

Identifier Type: OTHER

Identifier Source: secondary_id

RG1124486

Identifier Type: -

Identifier Source: org_study_id