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

NCT ID: NCT04243512

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-06-29

Brief Summary

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

Detailed 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.

Conditions

Cancer Survivorship

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Time-restricted eating

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.

Group Type: EXPERIMENTAL

Time-restricted eating

Intervention Type: BEHAVIORAL

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

Interventions

Time-restricted eating

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Amber Kleckner

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wilmot Cancer Institute

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36131848 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UMLT19187

Identifier Type: -

Identifier Source: org_study_id