Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256888
• Other study ID #: HP-00099067
• Secondary ID: UL1TR003098
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2023
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: University of Maryland, Baltimore
• Contact: Amber Kleckner, PhD
• Phone: 4107065961
• Email: amber.kleckner[@]umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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, and a higher score indicates less fatigue.	12 weeks