What is the mechanism of action of this treatment?

Common treatments for Frailty Syndrome, such as anti-inflammatory agents like Fisetin, work by reducing systemic inflammation, which is a major contributor to the symptoms of frailty. These treatments target inflammatory pathways to decrease levels of inflammatory markers in the blood. This reduction in inflammation can lead to improvements in muscle strength, reduced insulin resistance, and decreased bone resorption. By addressing these underlying issues, anti-inflammatory treatments can enhance physical function and quality of life for patients with Frailty Syndrome.

What side effects are associated with this type of intervention?

Anti-inflammatory treatments for Frailty Syndrome, such as Fisetin, aim to reduce inflammation and improve overall health markers in elderly adults. Common side effects of anti-inflammatory drugs can include gastrointestinal issues like nausea, vomiting, and diarrhea, as well as potential liver toxicity and allergic reactions. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

There is no specific information provided about prior FDA approvals for the treatment of Frailty Syndrome. However, Fisetin, an anti-inflammatory drug, is being studied for its potential to reduce inflammation and frailty in elderly adults. Similar treatments that focus on anti-inflammatory properties may include other drugs that target inflammation, but specific FDA-approved drugs for Frailty Syndrome are not mentioned in the provided context.

What other types of research exist?

Promising, novel alternatives to Fisetin for treating frailty syndrome in 2024 include TNF-α antagonists such as Etanercept and Infliximab, as well as Thalidomide. These agents have demonstrated anti-inflammatory effects and potential benefits in related conditions.

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Flavonoid

Fisetin for Frailty (AFFIRM-LITE Trial)

Phase 2

Waitlist Available

Led By Robert Pignolo, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 70 years

Be older than 65 years old

Must not have

Strong inhibitors of CYP3A4

New/active invasive cancer except non-melanoma skin cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up seven days

Summary

This trial tests if Fisetin can reduce inflammation and frailty in elderly adults. Fisetin may help by lowering oxidative stress and improving overall health. The study focuses on older adults because they often face these health issues. Fisetin is a natural flavonoid found in many fruits and vegetables, known for its anti-inflammatory and antioxidant properties.

Who is the study for?

This trial is for people aged 70 or older who are experiencing frailty and inflammation. They must be able to take oral medication and not be on certain drugs that can't be stopped for the duration of the trial, including strong CYP3A4 inhibitors, proton pump inhibitors without a break, or senolytic agents used in the past year. Pregnant individuals, those with specific infections like hepatitis B/C or HIV, recent cancer except non-melanoma skin cancers, and those with certain lab abnormalities cannot join.

What is being tested?

The study is testing Fisetin's ability to reduce signs of aging such as frailty and inflammation compared to a placebo. Participants will receive either Fisetin capsules or a placebo (a capsule with no active drug) to see if there's an improvement in their condition.

What are the potential side effects?

Potential side effects from Fisetin may include allergic reactions for those sensitive to it. Since this is a pilot study assessing efficacy and safety, detailed side effect profiles will be determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 70 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking strong CYP3A4 inhibitors.

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I have a new or active cancer that is not a non-melanoma skin cancer.

Select...

I cannot take medicine by mouth.

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I have an invasive fungal or viral infection.

Select...

My vitamin D level is above 20 ng/ml.

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I am currently on or have been treated with tyrosine kinase inhibitor therapy.

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I am currently on medication that includes chemotherapy drugs.

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I am not currently taking any antibiotics or antifungals listed.

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I cannot or will not stop my proton pump inhibitor medication for 4 days during the Fisetin treatment.

Select...

My weight is over 150 kg or my BMI is over 50.

Select...

I cannot or do not want to give permission for treatment.

Select...

I have an active hepatitis B or C infection.

Select...

I am HIV positive.

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I have unmanaged fluid buildup in my chest or abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ seven days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~seven days

This trial's timeline: 3 weeks for screening, Varies for treatment, and seven days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decrease in blood inflammation markers

Side effects data

From 2023 Phase 1 & 2 trial • 75 Patients • NCT04210986

38%

Arthralgia

15%

Pain in Extremity

12%

Lab Findings

12%

Nausea

Fatigue

Back Pain

Headache

Muscle Cramp

Dry Mouth

Flatulence

Rash Maculo-Papular

Covid 19

Neoplasms

Bladder Perforation

Rotator Cuff Injury

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fisetin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Fisetin 20mg/kg/day, orally for 2 consecutive days

Group II: PlaceboPlacebo Group1 Intervention

Placebo capsules orally for 2 consecutive days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fisetin

2016

Completed Phase 2

~250

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Frailty Syndrome, such as anti-inflammatory agents like Fisetin, work by reducing systemic inflammation, which is a major contributor to the symptoms of frailty. These treatments target inflammatory pathways to decrease levels of inflammatory markers in the blood. This reduction in inflammation can lead to improvements in muscle strength, reduced insulin resistance, and decreased bone resorption. By addressing these underlying issues, anti-inflammatory treatments can enhance physical function and quality of life for patients with Frailty Syndrome.