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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05256888
Other study ID # HP-00099067
Secondary ID UL1TR003098
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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