NCT05256888

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue: The Fatigue REDuction After Cancer (FREDA) Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism. The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.

Conditions

• Neoplasms
• Therapy
• Fatigue
• Diet Therapy
• Time
• Survivorship
• Fasting, Intermittent

Interventions

Type	Name	Description
BEHAVIORAL	Time-restricted eating	12 weeks of time-restricted eating (10-hour window)
BEHAVIORAL	Healthy lifestyle education	Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks

Timeline

• Start date: 2023-01-26
• Primary completion: 2024-06-01
• Completion: 2026-04-01
• First posted: 2022-02-25
• Last updated: 2025-05-07
• Results posted: 2025-05-07

Locations

1 site across 1 country: United States