Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

University of Maryland Baltimore (UMB)

Status: Active, not recruiting

Conditions: Time; Neoplasms; Diet Therapy; Survivorship; Therapy; Fatigue; Fasting, Intermittent

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05256888

HP-00099067

UL1TR003098 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Time-restricted eating

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy lifestyle education

Behavioral: Time-restricted eating

Control

Other group

Description:

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

Treatment:

Behavioral: Healthy lifestyle education