Randomized Clinical Trial Testing Meal Timing Effects During Cancer Treatment in Alaska Native and American Indian Patients with Rectal or Breast Cancer

What this Trial Is About

This clinical trial is investigating meal timing as a new and sustainable approach during cancer treatment to improve therapy response and metabolic health. It focuses on patients with rectal or breast cancer receiving neoadjuvant treatment at the Alaska Native Medical Center. The study is based on evidence that fasting may enhance cancer treatment effects by sensitizing tumor cells while protecting healthy cells, but extended fasting can be difficult and risky. Time-restricted eating TRE may be a simpler alternative that also benefits metabolic health. Participants are randomly assigned to either the TRE group, eating only within an 8-hour window each day starting 1-3 hours after waking, or to a control group with a 12-hour or longer eating period. This intervention begins within 1 to 2 weeks after starting cancer treatment and continues until the treatment ends, lasting about 6 months. Participants in both groups record their meal times daily, receive electronic reminders, and have weekly calls for support. They also receive nutrition counseling weekly for the first month and monthly thereafter. Researchers use surveys, food records, continuous glucose monitoring, and biospecimen collection to monitor adherence and effects. During the study, participants complete questionnaires at intake and follow-ups while blood and stool samples are collected. Researchers assess treatment response, toxicity, treatment delivery, tumor measures, adverse events, quality of life, and survival outcomes at various time points up to 24 months after treatment. The study monitors how meal timing affects these outcomes, metabolic health, and adherence. Participation includes regular contact with study staff and nutrition support throughout the intervention period.

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