Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia
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|ClinicalTrials.gov Identifier: NCT03476330|
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fanconi Anemia Squamous Cell Carcinoma||Drug: Quercetin (dietary supplement)||Phase 2|
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). Currently, the only curative treatment option for the hematological complications of FA include hematopoietic cell transplantation (HCT). 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.
This study is an open-label, single arm study. This study will enroll 38 post-HCT patients with FA, and up to 7 patients with FA without history of HCT. In both groups, patients with or without evidence of any pre-malignant lesions concerning for SCC, history of SCC or active SCC may be allowed to participate if they wish so and at the discretion of the PI. All patients will be treated with oral quercetin for a total of 24 months.
The investigators will determine the efficacy of Quercetin in reducing buccal micronuclei (a surrogate marker of DNA damage and susceptibility to squamous cell carcinoma due to genomic instability) in post-HCT patients with fanconi anemia (FA).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia|
|Actual Study Start Date :||May 8, 2018|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
All patients will be treated with oral quercetin for a total of 24 months.
Drug: Quercetin (dietary supplement)
Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
- Reduction of buccal micronuclei [ Time Frame: Up to 30 months ]Efficacy of Quercetin in reducing buccal micronuclei
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476330
|Contact: Stephanie A Edwards, BSN, RN||513-636-9292||StephanieL.Edwards@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Stephanie L Edwards, BSN, RN 513-636-9292 StephanieL.Edwards@cchmc.org|
|Principal Investigator: Parinda A Mehta, MD|
|Principal Investigator:||Parinda A Mehta, MD||Cincinnati Children's Hosptial Medical Center|