Trial Outcomes & Findings for Time-Restricted Eating to Address Persistent Cancer-Related Fatigue (NCT NCT05256888)
NCT ID: NCT05256888
Last Updated: 2025-05-07
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
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-05-07
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=93 Participants
|
53.7 years
STANDARD_DEVIATION 16.8 • n=4 Participants
|
54.1 years
STANDARD_DEVIATION 14.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
30 participants
n=27 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