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Flavonoid

Quercetin for Squamous Cell Cancer in Fanconi Anemia

Phase 2
Waitlist Available
Led By Parinda A Mehta, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients ≥2 years
Able to take enteral medication
Must not have
Renal failure requiring dialysis
Patients who have received quercetin supplementation or other antioxidants within the last 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the supplement quercetin can prevent or delay the development of skin cancer in people with Fanconi anemia, a rare disease that leads to bone marrow failure and a higher risk for certain cancers.

Who is the study for?
This trial is for individuals over 2 years old with Fanconi anemia (FA), who can take medication by mouth. It's not for those pregnant, breastfeeding, at risk of pregnancy without birth control, or have taken antioxidants like quercetin in the last month. People undergoing cancer treatments or with certain liver and kidney conditions, or on digoxin therapy that can't be stopped are also excluded.
What is being tested?
The study tests if a dietary supplement called Quercetin can prevent or delay Squamous Cell Carcinoma (SCC) in patients with FA. The goal is to reduce the need for harsher treatments like chemotherapy and radiation therapy which are typically used to treat SCC.
What are the potential side effects?
While specific side effects of Quercetin aren't detailed here, as a dietary supplement it could potentially cause digestive issues, headaches, and may interact with medications such as blood thinners and chemotherapy drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 2 years old or older.
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I can take medicine by mouth.
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I have been diagnosed with Fanconi anemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on dialysis for kidney failure.
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I haven't taken quercetin or other antioxidants in the last 30 days.
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I am currently undergoing treatment for squamous cell carcinoma.
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I am on digoxin and cannot stop it for medical reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction of buccal micronuclei

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: QuercetinExperimental Treatment1 Intervention
All patients will be treated with oral quercetin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quercetin (dietary supplement)
2012
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
835 Previous Clinical Trials
6,565,119 Total Patients Enrolled
9 Trials studying Fanconi Anemia
205 Patients Enrolled for Fanconi Anemia
Parinda A Mehta, MDPrincipal InvestigatorCincinnati Children's Hosptial Medical Center

Media Library

Quercetin (Flavonoid) Clinical Trial Eligibility Overview. Trial Name: NCT03476330 — Phase 2
Fanconi Anemia Research Study Groups: Quercetin
Fanconi Anemia Clinical Trial 2023: Quercetin Highlights & Side Effects. Trial Name: NCT03476330 — Phase 2
Quercetin (Flavonoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03476330 — Phase 2
~5 spots leftby Oct 2025
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