Recruiting

Fisetin

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06819254

Conditions

Fatigue

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Fisetin followed by Placebo

Placebo followed by Fisetin

Study Details

Brief summary:

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

Conditions

Fatigue

Study ID

NCT06819254

Start date

Dec 9, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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
  • 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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Fisetin - Placebo

Two-week regimen of Fisetin supplement followed by two-week regimen of placebo.

experimental: Placebo - Fisetin

Two-week regimen of placebo followed by two-week regimen of Fisetin supplement.

Interventions

Fisetin followed by Placebo

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 followed by Fisetin

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.

Primary outcome measure

  • Change in Pittsburgh Fatigability Scale (PFS) [ Time Frame: Baseline to Week 2 ]
  • Change in Pittsburgh Fatigability Scale (PFS) [ Time Frame: Baseline to Week 4 ]
  • Change in Pittsburgh Fatigability Scale (PFS) [ Time Frame: Baseline to Week 6 ]
  • Change in Pittsburgh Fatigability Scale (PFS) [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Kimberly Kennedy

336-713-8567kkennedy@wakehealth.edu

Locations

Atrium Health Wake Forest Baptist Hospital

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Kim Kennedy, MS

336-713-8567kennedy@wakehealth.edu

Principal Investigator:

Stephen Kritchevsky, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • cancer survivor
  • supplement
  • Fisetin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-12-15.