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

NCT04243512 | Completed Results

• 1 other identifier: UMLT19187
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Survivorship

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Time-restricted eating

EXPERIMENTAL

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.

Behavioral: Time-restricted eating

Interventions

Time-restricted eating BEHAVIORAL

Restrict food and beverage intake (except water) to a 10-hour window

Time-restricted eating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Kleckner AS, Altman BJ, Reschke JE, Kleckner IR, Culakova E, Dunne RF, Mustian KM, Peppone LJ. Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study. J Integr Oncol. 2022;11(5):379. Epub 2022 May 30.

  PMID: 36131848 DERIVED

Results Point of Contact

• Title: Amber Kleckner
• Organization: University of Maryland Baltimore

amber.kleckner@umaryland.edu

410-706-5961

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: June 30, 2020
• Primary Completion: September 1, 2021
• Study Completion: June 29, 2022
• Last Updated: May 11, 2023
• Results First Posted: May 11, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)