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Completed

NCT Number: NCT04243512

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilmot Cancer Institute

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time-restricted eating

Behavioral

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

Primary outcomes

  1. Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern

    Time frame: 14 days

    Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 28, 2020
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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