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

Cancer Survivorship Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243512
• Other study ID #: UMLT19187
• Status: Completed
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: June 29, 2022

Study information

• Verified date: June 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 29, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Survivorship

Intervention

Behavioral:
• Time-restricted eating
Restrict food and beverage intake (except water) to a 10-hour window

Locations

Country	Name	City	State
United States	Wilmot Cancer Institute	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern	Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern	14 days