Trial Outcomes & Findings for Time-Restricted Eating to Address Persistent Cancer-Related Fatigue (NCT NCT05256888)
NCT ID: NCT05256888
Last Updated: 2026-07-20
Results Overview
To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-07-20
Participant Flow
Participants must have completed baseline assessments, including the FACIT-F questionnaire, in order to be randomized. There were 20 people who consented to the study but did not complete baseline assessments and therefore were not randomized to an arm.
Participant milestones
| Measure |
Time-restricted Eating
Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.
Time-restricted eating: 12 weeks of time-restricted eating (10-hour window)
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
Control
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
Baseline characteristics by cohort
| Measure |
Time-restricted Eating
n=15 Participants
Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.
Time-restricted eating: 12 weeks of time-restricted eating (10-hour window)
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
Control
n=15 Participants
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 12.7 • n=20 Participants
|
53.7 years
STANDARD_DEVIATION 16.8 • n=20 Participants
|
54.1 years
STANDARD_DEVIATION 14.7 • n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=20 Participants
|
15 participants
n=20 Participants
|
30 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 12 weeksTo assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
Outcome measures
| Measure |
All Participants
n=50 Participants
All participants
|
Control
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
|---|---|---|
|
Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study
|
25 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeksFACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long. The scale is from 0-52, and a higher score indicates less fatigue.
Outcome measures
| Measure |
All Participants
n=11 Participants
All participants
|
Control
n=14 Participants
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
|---|---|---|
|
Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire
|
38.7 score on a scale
Standard Deviation 9.2
|
37.2 score on a scale
Standard Deviation 9.1
|
Adverse Events
Time-restricted Eating
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Time-restricted Eating
n=15 participants at risk
Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.
Time-restricted eating: 12 weeks of time-restricted eating (10-hour window)
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
Control
n=15 participants at risk
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/15 • 13 weeks
|
6.7%
1/15 • Number of events 1 • 13 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/15 • 13 weeks
|
6.7%
1/15 • Number of events 1 • 13 weeks
|
Other adverse events
| Measure |
Time-restricted Eating
n=15 participants at risk
Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship.
Time-restricted eating: 12 weeks of time-restricted eating (10-hour window)
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
Control
n=15 participants at risk
Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship.
Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and diarrhea
|
6.7%
1/15 • Number of events 1 • 13 weeks
|
0.00%
0/15 • 13 weeks
|
Additional Information
Amber Kleckner, PhD
University of Maryland School of Nursing
Phone: 410-706-5961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place