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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Fatigue

In brief

The purpose of this study is to find out if taking a Fisetin supplement can decrease fatigue among older cancer survivors.

Key facts

Study ID: NCT06819254
Run by: Wake Forest University Health Sciences
People needed: 60
Starts: 2025-12-09
Expected to finish: 2026-12-31
Last updated by the study team: 2025-12-15

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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).

You may not qualify if…

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)
Drugs listed as part of the exclusion criteria are not permitted during each of the two 2-day courses of treatment with Fisetin. If patients are required to initiate these medications within the 2-day period, they will be removed from the study primarily due to risk of drug-drug interaction.
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

Where it is running

Atrium Health Wake Forest Baptist Hospital — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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