Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

NCT05256888 | Active Not Recruiting Results DMC

• 2 other identifiers: HP-00099067UL1TR003098
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study

  To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.

  12 weeks

• Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire

  FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long. The scale is from 0-52, and a higher score indicates less fatigue.

  12 weeks

Study Arms (2)

Time-restricted eating

EXPERIMENTAL

Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.

Behavioral: Time-restricted eating; Behavioral: Healthy lifestyle education

Control

OTHER

Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.

Behavioral: Healthy lifestyle education

Interventions

Time-restricted eating BEHAVIORAL

12 weeks of time-restricted eating (10-hour window)

Time-restricted eating

Healthy lifestyle education BEHAVIORAL

Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks

Control; Time-restricted eating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer, including chemotherapy for hematologic neoplasms, at least 2 months and not more than 2 years prior to enrolling,
• Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
• Be able to speak and/or read and write in English,
• Be at least 18 years old,
• Own a smartphone,
• Be willing and able to adhere to study procedures, including use of a smartphone app, and
• Be able to provide informed consent.

You may not qualify if:

• Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week,
• Be underweight, as defined as a body mass index ≤18.5 kg/m2,
• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Kleckner AS, Clingan CL, Youngblood SM, Kleckner IR, Quick L, Elrod RD, Zhu S, Manoogian ENC, Panda S, Badros AZ, Emadi A. Time-restricted eating to address persistent cancer-related fatigue among cancer survivors: a randomized controlled trial. Support Care Cancer. 2025 Apr 5;33(4):353. doi: 10.1007/s00520-025-09394-w.

  PMID: 40186671 DERIVED

MeSH Terms

Conditions

Neoplasms; Fatigue; Intermittent Fasting

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Results Point of Contact

• Title: Amber Kleckner, PhD
• Organization: University of Maryland School of Nursing

amber.kleckner@umaryland.edu

410-706-5961

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: January 26, 2023
• Primary Completion: June 1, 2024
• Study Completion: April 1, 2026
• Last Updated: May 7, 2025
• Results First Posted: May 7, 2025

Record last verified: 2025-05

Locations

US (1)