NCT06819254

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Fatigue

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-11
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study