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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 complete questionnaires at intake and subsequent follow-up assessments."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether eating within a shorter time each day can help cancer treatment work better and improve how the body uses food for energy. It is for Alaska Native or American Indian adults getting cancer care at the Alaska Native Medical Center (ANMC), including people with breast or rectal cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 21 or older, identify as Alaska Native or American Indian, and qualify for care at ANMC.
  • For treatment before surgery: have rectal cancer at stage II or III, or stage IV if treatment aims to cure it; or HER2-positive or triple-negative breast cancer at stage I, II, or III. These breast cancer types are based on proteins found on the cancer cells.
  • For treatment after surgery: have a solid tumor confirmed by testing tissue or cells.
  • Have a body mass index (BMI), a measure of weight for height, of at least 18.5.
  • Plan to receive cancer treatment before or after surgery for more than 3 months.
  • Have completed no more than 4 weeks of that treatment before joining.
  • Be able to give informed consent and follow the study rules, visits, and tests.
  • Score below 4 on a survey about access to enough food, or have a dietitian's approval if the score is above 5.

Who can't join

  • For treatment before surgery: had cell-killing chemotherapy within 12 months before the breast or rectal cancer diagnosis. Also excluded: an allergy to any treatment drug or any past radiation to the pelvis.
  • Have another active cancer needing treatment throughout the body, except adequately treated non-melanoma skin cancer or very early cervical cancer.
  • Had a hole in the stomach or intestines within the past 12 months, or have certain bowel disorders with severe or quickly worsening symptoms not caused by the current cancer.
  • Receive nutrition through a vein or feeding tube, or use similar nutrition supplements during the study.
  • Have uncontrolled heart failure rated class III or higher, or severe nerve damage rated grade 3 or higher.
  • Used an experimental drug or device in another study within 4 weeks of the first treatment dose, or are currently in such a study.
  • Are pregnant or breastfeeding, work overnight more than 1 day a week, or already eat within a window shorter than 10 hours on most days.
  • Have unstable mental health, sleep, or body-clock conditions, or severe mental health, thinking, substance use, or social problems that would prevent following study rules. Stable sleep apnea or depression is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 (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 sites (1)

AK