What is the mechanism of action of this treatment?

The most common treatments for Frailty Syndrome often target inflammation, as chronic inflammation is a key contributor to the condition. Anti-inflammatory agents, such as fisetin, work by reducing inflammation, which can improve insulin resistance, decrease bone resorption, and enhance physical function. This is crucial for Frailty Syndrome patients because reducing inflammation can help mitigate several symptoms associated with frailty, such as muscle weakness, decreased mobility, and increased risk of fractures, thereby improving overall quality of life and physical independence.

What side effects are associated with this type of intervention?

Common treatments for Frailty Syndrome, particularly anti-inflammatory agents, can have several side effects. These include an increased risk of infections, injection site reactions, gastrointestinal issues, and potential liver toxicity. Long-term use of these treatments may also lead to cardiovascular complications or bone density loss. It is important to discuss these potential side effects with a healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Frailty Syndrome. However, anti-inflammatory agents, which are being studied for their potential to reduce inflammation, improve insulin resistance, decrease bone resorption, and enhance physical function, are used in other conditions. For example, biologic agents like TNF-alpha inhibitors (e.g., etanercept, infliximab) and IL-12/23 inhibitors (e.g., ustekinumab) have shown benefits in reducing inflammation and improving related health outcomes in conditions such as psoriasis and psoriatic arthritis.

What other types of research exist?

A promising novel alternative to traditional anti-inflammatory agents for treating frailty syndrome in 2024 is fisetin. Fisetin is a flavonoid being studied for its potential to reduce inflammation, improve insulin resistance, decrease bone resorption, and enhance physical function in elderly patients. Further clinical trials are needed to confirm its efficacy and safety.

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Flavonoid

Fisetin for Frailty (AFFIRM Trial)

Phase 2

Waitlist Available

Led By Robert J 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

Healthy postmenopausal women

Must not have

Hypopituitarism

Malabsorption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month

Summary

This trial aims to see if Fisetin, a natural substance from fruits and vegetables, can help elderly postmenopausal women with walking difficulties by reducing inflammation and protecting cells. Fisetin is a natural flavonoid found in many fruits and vegetables, known for its anti-inflammatory, antioxidant, and anti-carcinogenic properties. The goal is to improve their overall health and physical function.

Who is the study for?

This trial is for healthy postmenopausal women aged 70 or older with gait disturbances. It's not for those with significant liver/renal disease, malabsorption issues, certain hormonal disorders, recent fractures, or on medications affecting bone turnover or inducing cellular senescence.

What is being tested?

The study tests if Fisetin can reduce inflammation and improve insulin resistance, bone health, and physical function in elderly women. Participants will receive either Fisetin or a placebo to assess the potential benefits of this intervention.

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions related to the supplement Fisetin. Typically such supplements could cause digestive discomfort among other mild symptoms.

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.

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I am a healthy woman who has gone through menopause.

Exclusion Criteria

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

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I have been diagnosed with hypopituitarism.

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I have issues absorbing nutrients from my food.

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I have problems absorbing nutrients from my food.

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I have been diagnosed with cancer, including myeloma.

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I am currently on medication that slows down cell aging.

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I have been diagnosed with acromegaly.

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I am currently taking certain medications to fight infections.

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I have had a gastric bypass or stomach reduction surgery.

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I have a muscle disorder related to abnormal calcium, vitamin D, or enzyme levels.

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I am on medication that affects bone health.

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I am not on drugs that can't be paused for Fisetin treatment.

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I have had a bone break in the last year.

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I have a serious liver or kidney disease.

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I cannot take medicine by mouth.

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I am taking medication to prevent blood clots.

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I am diabetic and take sulfonylureas, SGLT2 inhibitors, or insulin.

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My kidney function is severely reduced.

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I have hypoparathyroidism.

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I have hyperparathyroidism.

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I have been diagnosed with Cushing's syndrome.

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I have not taken any senolytic agents in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month

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

Treatment Details

Study Objectives

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

Primary study objectives

Improved 6 minute walk

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

Flatulence

Dry Mouth

Rash Maculo-Papular

Covid 19

Bladder Perforation

Neoplasms

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 20/mg/kg/day, orally for 2 consecutive days, for 2 consecutive months.

Group II: PlaceboPlacebo Group1 Intervention

Placebo capsules orally for 2 consecutive days, for 2 consecutive months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fisetin

2016

Completed Phase 2

~250

0 / 23Eligibility 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

The most common treatments for Frailty Syndrome often target inflammation, as chronic inflammation is a key contributor to the condition. Anti-inflammatory agents, such as fisetin, work by reducing inflammation, which can improve insulin resistance, decrease bone resorption, and enhance physical function. This is crucial for Frailty Syndrome patients because reducing inflammation can help mitigate several symptoms associated with frailty, such as muscle weakness, decreased mobility, and increased risk of fractures, thereby improving overall quality of life and physical independence.