Fisetin for Fatigue

Overseen By Kimberly Kennedy

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Wake Forest University Health Sciences

Must not be taking: Warfarin, Steroids, CYP3A4 drugs

Disqualifiers: Hypertension, Heart failure, Lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, especially those that interact with specific enzymes (like CYP3A4) or have a narrow therapeutic range, during specific times of the study. If you are taking warfarin, Coumadin, or steroids, you cannot participate. You may need to pause other medications for short periods during the trial.

How does the drug fisetin differ from other treatments for fatigue?

Fisetin is unique because it is a natural flavonoid with antioxidant and anti-inflammatory properties, which may help reduce fatigue by protecting against oxidative stress and inflammation. Unlike many standard treatments, fisetin also has neuroprotective effects, potentially benefiting brain health and function. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Stephen Kritchevsky, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for older adult cancer survivors who've been cancer-free for over a year, have completed all cancer treatments at least 6 months ago but less than 5 years ago, and are experiencing fatigue. Participants must be able to walk (with cane or walker if needed) and swallow capsules. Those with certain health conditions, taking specific medications like warfarin, or unable to consent are excluded.

Inclusion Criteria

I had cancer (not skin cancer) over a year ago but am now cancer-free.

My blood cancer is in remission.

I have had cancer treatments like surgery, radiation, or chemotherapy.

Exclusion Criteria

I am currently on warfarin or Coumadin.

I am on dialysis for end-stage kidney disease.

Unable or unwilling to give informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Fisetin or placebo for two weeks, followed by a 14-day wash-out and then a cross-over to the alternate regimen for another two weeks.

4 weeks

2 visits (in-person) at baseline and day 14

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up assessments at weeks 1, 5, and a post-treatment phone call at week 12.

12 weeks

Follow-up phone calls at weeks 1 and 5, assessments at weeks 2, 4, 6, and 12

Treatment Details

Interventions

• Fisetin

Trial Overview The study is testing whether Fisetin supplements can reduce fatigue in these individuals. It's set up so that some participants first take Fisetin then a placebo, while others start with the placebo followed by Fisetin to compare the effects.

Participant Groups

Group I: Placebo - Fisetin Experimental Treatment 1 Intervention

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

Group II: Fisetin - Placebo Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

The Ambrose Monell Foundation

Collaborator

Trials

1

Recruited

60+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Preventing and Treating Neurological Disorders with the Flavonol Fisetin. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Phytomedicine-Based Potent Antioxidant, Fisetin Protects CNS-Insult LPS-Induced Oxidative Stress-Mediated Neurodegeneration and Memory Impairment. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Fisetin Protects PC12 Cells from Tunicamycin-Mediated Cell Death via Reactive Oxygen Species Scavenging and Modulation of Nrf2-Driven Gene Expression, SIRT1 and MAPK Signaling in PC12 Cells. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Small Molecule Fisetin Modulates Alpha-Synuclein Aggregation. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Fisetin provides neuroprotection in pentylenetetrazole-induced cognition impairment by upregulating CREB/BDNF. [2023]