Clinical trial · Interventional
Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study
NCT04243512CI-TRIAL-00066365completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Time-restricted eating | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Time-restricted eating
- description
- 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.
- interventionNames
- Behavioral: Time-restricted eating
Primary outcomes (1)
- measure
- Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern
- timeFrame
- 14 days
- description
- Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKleckner 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