N/A
N=39
Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study
Cancer Survivorship
Bottom Line
View on ClinicalTrials.gov: NCT04243512 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern — 90.1 percent of days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Time-restricted eating (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern |
90.1 | — |
Summary
The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04243512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.