Fatigue is a common side effect of cancer treatment, and it can linger well into survivorship. Time-restricted eating, which is the practice of confining eating into a specific window of hours each day, may be able to improve sleep quality and reduce persistent fatigue among cancer survivors by training the individual's circadian rhythm to provide more energy during the day and reduce wakefulness at night. The Fatigue REDuction After cancer (FREDA) trial is designed to test this idea.

"Nutrition guidelines are vague when it comes to cancer survivorship. Survivors often want specific nutrition recommendations to follow, and while time-restricted eating (sometimes called intermittent fasting) has gotten a lot of attention in the media, studies to determine the efficacy of specific nutrition plans just don't exist yet," said FREDA trial lead Amber Kleckner, PhD, Assistant Professor in the Department of Pain and Translational Symptom Science, University of Maryland School of Nursing; Associate Member, University of Maryland Greenebaum Comprehensive Cancer Center; and Director of The METRICCs Lab. "We were one of the first in the world to do a time-restricted study in the cancer population. This is cutting-edge research in the oncology nutrition space."

How the FREDA trial works

Participation in the FREDA trial is completely remote, and the study is continuing to enroll participants. The trial is open to survivors of any kind of cancer, and people can sign up at any University of Maryland Medical System cancer center. Study participants start by engaging in a virtual meeting with a nutritionist, where they can talk about their current diet, ask any nutrition-related questions, and develop goals for what they may want to change, nutrition-wise.

Half of the study's participants will be randomly assigned to the 10-hour time restricted eating group. These participants choose a 10-hour daytime window during which they consume all of their food (and caloric beverages) for the next 12 weeks. The other half of the participants will not restrict their eating to a certain time window. During weeks 1, 6, and 12, all participants are mailed a packet with a questionnaire, a food log, and devices to monitor their activity and glucose levels. At the end of those weeks, the participants drop the completed materials back in the mail. The nutritionist or a licensed clinical dietitian will contact participants every couple of weeks during the study to answer questions and check in. Each participant who completes the study will receive compensation.

Trial eligibility and future study plans

To be eligible to participate, individuals must have had cancer treatment within the last two years and report consistent fatigue. People who already restrict their eating to a 10-hour window, those who are underweight, and those who have certain contraindications are not eligible for the trial.

The FREDA trial is a feasibility study, the results of which will guide future studies. If the trial data is promising, future studies plan to look at the mechanisms through which nutrient timing is affecting symptoms. "The goal of our research program, broadly speaking, is to have reliable nutrition guidelines that are more specific, enabling us to reduce the symptom burden in survivorship," Dr. Kleckner said.

This study is currently enrolling at the following University of Maryland Medical System cancer sites:

  • UM Greenebaum Comprehensive Cancer Center
  • Tate Cancer Center at UM Baltimore Washington Medical Center
  • Kaufman Cancer Center at UM Upper Chesapeake Health
  • Cancer Center at Shore Regional Health

To inquire about the FREDA trial, or to enroll a patient, contact the lead coordinator, Carin Clingan, MS, CNC, at carin.clingan@umaryland.edu.