Who is eligible for clinical trial NCT06819254?

Participants must meet protocol criteria for Fatigue. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06819254 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-12-09

Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors (NCT06819254)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Wake Forest University Health Sciences

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (30 items).

Location: Atrium Health Wake Forest Baptist Hospital — Winston-Salem, North Carolina

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Atrium Health Wake Forest Baptist Hospital — Winston-Salem, North Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗