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Pilot Study of Fisetin for Fatigue in Older Adult Cancer Survivors

This study is looking into whether a supplement called Fisetin can help reduce fatigue in older adults who have survived cancer. You might be able to join if you are 65 or older, have a history of certain types of cancer (excluding non-melanoma skin cancer) diagnosed over a year ago, and are currently free of disease. The study will measure changes in your fatigue levels using a tool called the Pittsburgh Fatigability Scale (PFS) at different points over six weeks. The current status of this study is unclear.

Study design
This is a double-blind, placebo-controlled study, meaning neither you nor the study staff will know if you are receiving Fisetin or a placebo (an inactive substance). It is a crossover trial, so you will receive both Fisetin and placebo at different times. The study plans to enroll 60 participants.
What's involved
You will take Fisetin or placebo twice daily for two consecutive days over two weeks, followed by a 14-day break. Then, you will switch to the other treatment for another two weeks. You will have blood draws and assessments at weeks 2, 4, and 6, with phone calls at weeks 1, 5, and 12.
Compensation
Not stated in the trial record.
Follow-up
Your fatigue levels will be assessed at 2, 4, and 6 weeks after starting the study, and a final safety phone call will be made at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06819254

Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors

Recruiting
PHASE4Ages 65+Interventional
Wake Forest University Health Sciences
~60 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:Fisetin followed by PlaceboPlacebo followed by Fisetin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pittsburgh Fatigability Scale (PFS)
Measured over Baseline to Week 2
+3 more outcomes measured

Conditions

Fatigue

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Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Stephen Kritchevsky, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Kimberly Kennedy
[email protected]
336-713-8567
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Self-reported history of cancer diagnosed \> 12 months prior to enrollment excluding non-melanoma skin cancer with no evidence of disease at enrollment.
Eligible solid tumor cancer types include Stage 1-3 breast, lung, head and neck, colorectal, anal, prostate, melanoma, bladder/ureteral, esophageal, gastric, pancreatic, kidney, liver/biliary, uterine, cervical, ovarian, sarcoma. (superficial disease and in situ disease only is excluded)
Eligible hematologic malignancies include lymphoma any subtype any stage in remission, multiple myeloma in remission, leukemia any subtype in remission.
Eligible prior cancer treatment modalities include surgery, radiation, chemotherapy, hormonal therapies, immunotherapy, biologic therapies.
All anti-cancer therapy completed \> 6 months prior to enrollment with \< 5 years from treatment
Presence of self-reported fatigue defined by a response of "somewhat, quite a bit, or very much" to the screening question "During the past seven days, did you feel fatigued: Not at all, a little bit, somewhat, quite a bit, very much?"
Ability to walk without requiring assistance from another individual (use of cane or walker acceptable)
Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion

Unable or unwilling to give informed consent
Female patients are of childbearing potential, defined as postmenopausal for at least 1 year.
Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia
Currently taking warfarin or Coumadin
Currently taking a steroid medication either regularly or within the last two weeks.
Patients currently taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, OATP1B1 (Unless willing and able to stop or modify the dosing of the drug) or strong inhibitors or inducers of CYP3A4 (e.g., cyclosporine, tacrolimus, or sirolimus) are excluded, unless medication can be safely held during the following times:
Immediately before the 1st IP administration (Day 0 or Day 30) until at least 10 hours after the 2nd IP administration (Day 1 or Day 31)
Immediately before the 3rd IP administration (Day 7 or Day 37) until at least 10 hours after the 4th IP administration (Day 8 or Day 38)
Subjects taking any of the medications listed in Appendix I may participate if they are otherwise eligible AND the medication can be safely held during the following times: Immediately before the 1st IP administration (Day 0 or Day 30) until at least 10 hours after the 2nd IP administration (Day 1 or Day 31); Immediately before the 3rd IP administration (Day 7 or Day 37) until at least 10 hours after the 4th IP administration (Day 8 or Day 38)
Uncontrolled hypertension (systolic \>170 OR diastolic \>100 mmHg) upon repeated assessments
Uncontrolled (as per clinical judgement) pleural/pericardial effusions or ascites
Active malignancy or on-going cancer treatment including oral anti-estrogen therapy, immunotherapy, biologic therapy.
Men receiving androgen deprivation therapy
Symptomatic congestive heart failure
Lung disease requiring oxygen
End stage renal disease requiring dialysis
Inability to swallow capsules
Chronic nausea or diarrhea defined by a frequency of ≥ once per week
Diagnosis of dementia
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Known untreated hypothyroidism
Allergy to fisetin
Human immunodeficiency virus infection
Known active untreated hepatitis B or C infection
Active invasive fungal infection
Unwilling to provide informed consent, including consent to access electronic health records
Judged unsuitable for the trial for any reason by research team
The following laboratory tests as indicated or as per clinical judgement: Normal organ and marrow function as defined: Hemoglobin \<10g/dL, leukocytes \<3,000/mcL, absolute neutrophil count \<1,500/mcL, platelets \<100,000/mcL, total bilirubin above normal institutional limits, AST(SGOT)/ALT(SGPT) \>2.5 X institutional upper limit of normal, creatinine clearance \<30 mL/min, fasting glucose \>300 on day of screening (from plasma or serum)

What this trial measures

  • Change in Pittsburgh Fatigability Scale (PFS)Baseline to Week 2

    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.

  • Change in Pittsburgh Fatigability Scale (PFS)Baseline to Week 4

    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.

  • Change in Pittsburgh Fatigability Scale (PFS)Baseline to Week 6

    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.

  • Change in Pittsburgh Fatigability Scale (PFS)Baseline to Week 12

    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.