Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia

Completed · Phase 2

Conditions studied: Fanconi Anemia, Squamous Cell Carcinoma

In brief

Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone marrow failure, variable congenital abnormalities and a predisposition to malignancy, particularly acute myeloid leukemia (AML) and squamous cell carcinoma (SCC). Improved transplant outcomes are modifying the natural history of Fanconi Anemia. Improved transplant survival, no radiation exposure, and almost no GVHD increases the importance of addressing later SCC even further. The investigators hypothesize that quercetin will prevent or delay the development of SCC and associated complications, there by ameliorating or delaying the need for potentially lethal treatment with chemotherapy and/or radiation therapy for the same. Funding Source - FDA Office of Orphan Products Development (OOPD)

Key facts

Study ID

NCT03476330

Run by

Children's Hospital Medical Center, Cincinnati

People needed

48

Starts

2018-05-08

Expected to finish

2026-01-09

Last updated by the study team

2026-04-20

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of FA
• Able to take enteral medication
• Patients ≥2 years

You may not qualify if…

• Renal failure requiring dialysis
• Total bilirubin >3 mg/dl and/or SGPT >200 at time of enrollment
• Patients receiving digoxin therapy, who are unable to discontinue either treatment due to medical reasons
• Patients who are pregnant or breastfeeding or are at risk of pregnancy or fathering a baby and are unable to use acceptable methods of birth control during the length of the study
• Patients who have received quercetin supplementation or other antioxidants within the last 30 days
• Patients receiving radiation therapy, chemotherapy or immunotherapy for treatment of SCC.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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