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Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

NCT05256888 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-07

Study results available
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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

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

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2024-06-01
Completion
2026-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05256888 on ClinicalTrials.gov