Fisetin for Fatigue
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a Fisetin supplement can reduce fatigue in older cancer survivors. Participants will take a Fisetin supplement and a placebo (a pill with no active ingredient) over several weeks to assess any impact on tiredness. Cancer survivors who completed treatment more than six months ago and frequently feel tired may be suitable for this trial. Participants must walk independently and cannot be on certain medications or undergoing ongoing cancer treatment. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.
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.
What is the safety track record for Fisetin?
Research has shown that fisetin is generally safe for most people. Although extensive safety data for humans is limited, fisetin is a common supplement and has not caused problems in animal studies. One study suggested that fisetin might protect brain cells without causing harm. However, possible side effects to monitor include signs of liver stress, such as fatigue, yellow skin, or dark urine.
Earlier studies with older adults reported no major side effects during short-term use. The advanced stage of this trial indicates that fisetin has already demonstrated a good safety record in previous research. Overall, fisetin appears safe, but monitoring for any unusual symptoms when taking the supplement is important.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about Fisetin for fatigue because it offers a natural approach to boosting energy levels, derived from fruits and vegetables like strawberries and apples. Unlike standard treatments for fatigue, which often involve stimulants or medications that might have side effects, Fisetin is a flavonoid with potential antioxidant and anti-inflammatory properties. This unique mechanism could help reduce fatigue by protecting cells from stress and damage, offering a promising alternative to existing options.
What evidence suggests that Fisetin might be an effective treatment for fatigue?
Research has shown that fisetin, a natural substance found in fruits and vegetables, has not been very effective in reducing tiredness. In past studies, fisetin did not outperform a placebo in easing tiredness or pain. Although fisetin is thought to aid healthy aging by reducing certain aging cells in the body, this has not resulted in clear benefits for relieving tiredness. This trial will compare a two-week regimen of fisetin followed by a placebo with a regimen of placebo followed by fisetin to further investigate its potential effects. Despite ongoing research into fisetin's possible health benefits, current evidence does not strongly support its ability to reduce tiredness in older cancer survivors.12678
Who Is on the Research Team?
Stephen Kritchevsky, PhD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
What Are the Treatments Tested in This Trial?
Interventions
- Fisetin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
The Ambrose Monell Foundation
Collaborator