Status:
ACTIVE_NOT_RECRUITING
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Neoplasms
Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05256888
Start Date
January 26 2023
End Date
April 1 2026
Last Update
May 7 2025
Active Locations (1)
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1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201