The purpose of this study is to find out if taking a Fisetin supplement can decrease fatigue among older cancer survivors.
Prospective double-blind placebo controlled, 14-day cross-over trial of patients aged 65 and over with a history of cancer with self-reported fatigue. Participants will be randomized and provided with Fisetin pills or placebo to take twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14 day wash-out. At the four-week visit participants will receive a cross-over placebo-controlled dosing regimen over two weeks. Follow-up phone calls for safety assessment and adherence review will occur at weeks 1 and 5. Follow-up assessments will be completed at 2, 4 and 6 weeks, and a post-treatment phone call assessment completed at 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
60
Fisetin 20 mg/kg per dose twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14-day wash-out. At the 4-week visit participants will receive a cross-over placebo-controlled dosing regimen to be taken twice daily on two consecutive days for two consecutive weeks.
Placebo twice daily on two consecutive days for two consecutive weeks. Participants will return on day 14 for a blood draw followed by a 14-day wash-out. At the 4-week visit participants will receive a cross-over Fisetin 20 mg/kg per dose twice daily on two consecutive days for two consecutive weeks.
Atrium Health Wake Forest Baptist Hospital
Winston-Salem, North Carolina, United States
RECRUITINGChange in Pittsburgh Fatigability Scale (PFS)
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Time frame: Baseline to Week 2
Change in Pittsburgh Fatigability Scale (PFS)
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Time frame: Baseline to Week 4
Change in Pittsburgh Fatigability Scale (PFS)
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Time frame: Baseline to Week 6
Change in Pittsburgh Fatigability Scale (PFS)
10-item PFS score is a measure of perceived fatigability in older adults and can serve as an adjunct to performance-based fatigability measures for identifying older adults at risk of mobility limitation in clinical and research settings. Total score range is 0-50 with higher score indicating greater fatigue.
Time frame: Baseline to Week 12
Change in Patient Reported Outcomes Measurement System (PROMIS)
PROMIS Fatigue Short-Form 7a - Item responses are rated on a five-point scale ranging from "never" to "always." Total score range is 5-35 with a higher scores indicating more fatigue.
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Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6, Baseline to Week 12
Change in Pepper Assessment Tool for Disability (PAT-D)
The (PAT-D) is a 19-item survey to assess domains of physical function in older adults. Responses are made on a five-point Likert scale ranging from "usually did with no difficulty" to "unable to do." Total score range is 19-95 with lower scores indicating better mobility and ability to perform activities of daily and instrumental activities of daily living.
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Expanded Short Physical Performance Battery (eSPPB)
eSPPB is used to objectively assess lower extremity physical function. This validated measure comprises a short walk, narrow walk, repeated chair stands, and balance tests. Total score range is 0-12 with higher scores indicating better physical performance. Lower scores on the eSPPB have been associated with increased risk of disability, hospitalization and worse survival among older adults with and without cancer.
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in 6-minute Walk Distance
Distance participant is able to walk in 6-minute will be measured. The 6-minute walk accurately assesses submaximal exercise capacity and is an independent predictor of mortality and is correlated with peak V02 testing.
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Fried Frailty Phenotype Score
Frailty score is calculated using the Frailty Index Calculation form. Score range is 0-5 with a higher score indicating frailty.
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
10-item questionnaire used to measure sedentary behavior. The average time per 24 hours spent on each individual sedentary activity will be recorded in hours and/or minutes. This will be done for an average weekday as well as for an average weekend day. Ranges from 0-24 hours with a higher score indicating more sedentary behavior.
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Change in PROMIS Global Health Short Form
PROMIS Global Health Short Form is a 10-item instrument assesses the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score, ranging from 4 to 20. Raw scores are converted to T-scores using the PROMIS conversion tables. Higher scores reflect greater fatigue.
Time frame: Baseline to Week 2, Baseline to Week 4, Baseline to Week 6
Medication Adherence Rate
Empty bottles from home will be returned. The number of pills taken is calculated by subtracting the count of the number of pills remaining from the total number of pills dispensed. The drug adherence rate is then calculated by dividing the number of pills taken by the number of pills they were supposed to take.
Time frame: Week 2, Week 5