Recruiting

Meal-Timing

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT06802172

Conditions

Rectal Cancer Stage II

Rectal Cancer Stage III

Breast Cancer Stage I

Rectal Cancer Stage IV

Breast Cancer Stage II

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Time-restricted eating

Questionnaire Administration

Biospecimen Collection

Health coaching

Study Details

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

Rectal Cancer Stage II

Rectal Cancer Stage III

Breast Cancer Stage I

Rectal Cancer Stage IV

Breast Cancer Stage II

Study ID

NCT06802172

Start date

Jul 23, 2026

Status verified date

Jun, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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 \[8 hours eating / 16 hours fasting per day (6+ days a week)\].

active comparator: Control group

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

Interventions

Time-restricted eating

Participate in time-restricted eating plan

Questionnaire Administration

Complete questionnaire

Biospecimen Collection

Undergo collection of blood and stool

Health coaching

Receive nutrition counseling

Primary outcome measure

  • Pathological Complete Response (pCR) rate [ Time Frame: At completion of neoadjuvant treatment (3-6 months) ]
  • Treatment-related toxicity [ Time Frame: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months) ]
  • Treatment Delivery (RDI and Completion) [ Time Frame: From enrollment until completion of neoadjuvant or adjuvant treatment (3-8 months) ]

Central Contacts and Locations

Central contacts

Locations

Alaska Native Medical Center (ANMC)

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Principal Investigator:

Timothy Thomas, MD

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Jul 29, 2026

Last verified

Jun, 2026

Keywords

  • Time-restricted eating
  • Time restricted eating
  • Meal timing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-07-29.