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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243512
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Amber Kleckner, University of Rochester

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

Condition or disease Intervention/treatment Phase
Cancer Survivorship Behavioral: Time-restricted eating Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study
Estimated Study Start Date : June 22, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2023

Arm Intervention/treatment
Experimental: 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.
Behavioral: Time-restricted eating
Restrict food and beverage intake (except water) to a 10-hour window




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243512


Contacts
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Contact: Amber S Kleckner, PhD 585-276-3440 amber_kleckner@urmc.rochester.edu

Locations
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United States, New York
Wilmot Cancer Institute Recruiting
Rochester, New York, United States, 14642
Contact: Amber Kleckner, PhD         
Sponsors and Collaborators
University of Rochester
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Responsible Party: Amber Kleckner, Research Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04243512    
Other Study ID Numbers: UMLT19187
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No