Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study

University of Rochester

Status: Completed

Conditions: Cancer Survivorship

Treatments: Behavioral: Time-restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT04243512

UMLT19187

Details and patient eligibility

About

The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.

Full description

In this study, the feasibility of delivering a time-restricted eating (TRE) intervention among fatigued cancer survivors will be assessed. The participants will be asked to eat ad libitum only within a self-selected 10-h window each day for 14 days. The primary aim is to assess the adherence of the participants to the 10-h TRE intervention.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Participants must...)

• Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 4 months and not more than 5 years prior to enrolling,
• Have a baseline level of fatigue, as determined by reporting a score of 3 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 English,
• Be at least 18 years old,
• Be willing and able to adhere to study procedures, and
• Be able to provide written informed consent.

Exclusion Criteria (Participants must not...):

• 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 ≤20.0 kg/m2.
• Not have surgery planned in the next month,
• Not 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),
• Not be taking insulin, or
• Be on enteral or parenteral nutrition.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Time-restricted eating

Experimental group

Description:

Participants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time.

Treatment:

Behavioral: Time-restricted eating