Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Take the Reins," is studying how the timing of meals can affect fatigue in cancer survivors. Fatigue is a common issue for people who have had cancer, and it can be very challenging, often lasting long after treatment has finished. Researchers want to see if eating all meals within a specific 10-hour window each day, known as time-restricted eating, can help reduce this fatigue compared to a regular eating pattern without restrictions. Participants will use a smartphone app to track what they eat and their weight, and they will be divided into two groups: one practicing time-restricted eating and the other receiving nutritional guidance without timing restrictions.

To be eligible for the trial, participants must be at least 18 years old, have been treated for certain types of blood cancer within the last two years, and report a moderate level of fatigue. They should also be able to read, write, and speak in English. Participants can expect to follow the eating plan for 12 weeks, with ongoing support and tracking, while contributing valuable information on how diet may influence their fatigue levels. This study aims to understand the potential benefits of meal timing on fatigue and overall health in cancer survivors.

Gender

ALL

Eligibility criteria

• Inclusion criteria (Participants must...):
• • Have a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma);
• • Be at least 2 months post-treatment with chemotherapy, radiation, targeted therapy, chimeric antigen receptor (CAR)-T cell therapy, stem cell transplant, or another therapy (maintenance therapies are okay; steady unchanged treatment for relapsed disease for \>2 months and expected to stay on it until progression is okay);
• * Have a baseline level of fatigue, as determined by at least one of the following:
• • 1. Reporting a score of 4 or higher in response to the question, "What was your worst fatigue in the last week, on a scale of 0-10, where 0 is no fatigue and 10 is the worst fatigue?"
• • 2. In the habit of taking daytime naps,
• • 3. Have fatigue that interferes with their ability to work, engage in social events, or is more than would be expected from physical exertion,
• • Be able to speak and/or read and write in English or Spanish;
• • Be at least 18 years old; and
• • Be able to provide informed consent.
• • Exclusion criteria (participants must not...)
• • Be underweight, as defined as a body mass index \<18.5 kg/m2;
• • Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week;
• • Be employed in a job where they regularly work away from the home at night (e.g., night shift);
• • Have surgery planned during the study duration;
• • Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder);
• • Be taking insulin; or
• • Be on enteral or parenteral nutrition.