Actively Recruiting
Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial
Led by Fred Hutchinson Cancer Center · Updated on 2026-05-22
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying meal timing as a new approach to improve cancer treatment results and metabolic health in patients with rectal or breast cancer receiving neoadjuvant therapy at the Alaska Native Medical Center. This trial focuses on an understudied population and explores time-restricted eating (TRE) as a sustainable alternative to extended fasting, which may help make cancer treatments more effective and reduce side effects by protecting healthy cells and targeting cancer cells. Participants will be randomly assigned to either a time-restricted eating group, which involves eating only during an 8-hour window starting 1-3 hours after waking, or a control group with a typical eating period of 12 or more hours daily. This intervention begins within 1-2 weeks after starting cancer treatment and continues until the end of treatment, about 6 months. Participants will track their meal times daily, receive weekly nutrition counseling in the first month, followed by monthly sessions, and provide blood and stool samples at various times. Throughout the study, participants will complete questionnaires and food records, and wear continuous glucose monitors to assess food intake and metabolic effects. Researchers will measure treatment response, toxicity, treatment delivery, tumor size, quality of life, and survival outcomes over periods ranging from 3 months to 2 years after treatment. Weekly calls and electronic reminders will help monitor adherence and gather data. The total study duration varies by participant based on their treatment schedule.
CONDITIONS
Brief Title
Effect of Meal Timing During Cancer Treatment in Patients in Alaska: A Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Self-identify as Alaska Native or American Indian and eligible for care at the Alaska Native Medical Center
- Age 21 years or older
- Histologically confirmed rectal cancer stage II, III, or IV (if curative) or HER2+ or triple negative breast cancer stage I, II, or III, or solid tumor
- Body mass index (BMI) 18.5 kg/m2 or higher
- Plan to receive neoadjuvant or adjuvant therapy for longer than 3 months
- Capacity to give informed consent
- Willing and able to adhere to study assessments, visit schedules, and restrictions
- Completed 4 weeks or less of neoadjuvant or adjuvant treatment before enrollment
- Score less than 4 on the U.S. Household Food Security Survey or clearance from dietitian if higher
You will not qualify if you...
- Cytotoxic chemotherapy within 12 months prior to rectal or breast cancer diagnosis
- Allergic reaction to any treatment agents
- Prior pelvic radiotherapy
- Active second cancer requiring systemic therapy (except treated non-melanoma skin cancer or cervical carcinoma in situ)
- History of gastrointestinal perforation within 12 months prior to enrollment
- Severe or rapidly worsening colonic or small bowel disorders unrelated to current cancer
- Receiving parenteral or enteral nutrition or similar supplements during the study
- Uncontrolled congestive heart failure (NYHA Class III or higher)
- Pre-existing grade 3 or higher neuropathy
- Participation in investigational agent or device studies within 4 weeks prior to treatment
- Unstable psychiatric, sleep, or circadian conditions (except stable sleep apnea or depression)
- Pregnant or breastfeeding
- Working overnight shifts more than 1 day per week
- Strictly following less than 10-hour eating windows on most days
- Severe psychiatric, cognitive, substance misuse, or social conditions interfering with study adherence
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 8 months, depending on treatment length
Participants follow their assigned meal timing plan during cancer treatment and receive nutrition counseling. They record meal times daily and participate in weekly counseling during the first month, then monthly counseling thereafter. Blood and stool samples are collected throughout treatment.
Weekly visits for nutrition counseling during the first month, then monthly visits thereafter
Duration - Up to 24 months post treatment completion
Participants complete follow-up assessments including questionnaires and survival monitoring after treatment ends.
Follow-up visits at 12 and 24 months after treatment completion
Trial Site Locations
Total: 1 location
1
Alaska Native Medical Center (ANMC)
Anchorage, Alaska, United States, 99508
Actively Recruiting
Research Team
T
Timothy Thomas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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