Neoplasms, Therapy, Fatigue, Diet Therapy, Time, Survivorship, Fasting, Intermittent
Conditions
Brief summary
This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism. The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.
Interventions
BEHAVIORALTime-restricted eating
12 weeks of time-restricted eating (10-hour window)
BEHAVIORALHealthy lifestyle education
Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer, including chemotherapy for hematologic neoplasms, at least 2 months and not more than 2 years prior to enrolling, * Have a baseline level of fatigue, as determined by reporting a score of 4 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 and/or read and write in English, * Be at least 18 years old, * Own a smartphone, * Be willing and able to adhere to study procedures, including use of a smartphone app, and * Be able to provide informed consent.
Exclusion criteria
* 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 ≤18.5 kg/m2, * Have surgery planned during the study duration, * 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), * Be taking insulin, or * Be on enteral or parenteral nutrition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study | 12 weeks | To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed. |
| Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire | 12 weeks | FACIT-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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Time-restricted Eating | Total | Control |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 12.7 | 54.1 years STANDARD_DEVIATION 14.7 | 53.7 years STANDARD_DEVIATION 16.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 28 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 16 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 13 Participants | 8 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 13 Participants | 23 Participants | 10 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 2 / 15 |
Outcome results
Primary
Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire
FACIT-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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | 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 |
| Control | Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire | 37.2 score on a scale | Standard Deviation 9.1 |
Comparison: In a linear model to assess group effects on fatigue at 12 weeks, adjusting for baseline levels of fatigue:~Effect of group = -1.77±1.08, p=0.11, favoring the TRE group.p-value: 0.11Regression, Linear
Primary
Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study
To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study | 25 Participants |