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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 November 2023 |
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Main ID: |
NCT03476330 |
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Date of registration:
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19/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia
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Scientific title:
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Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia |
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Date of first enrolment:
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May 8, 2018 |
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Target sample size:
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48 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03476330 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Parinda A Mehta, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cincinnati Children's Hosptial Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of FA
- Able to take enteral medication
- Patients =2 years
Exclusion Criteria:
- 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.
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fanconi Anemia
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Squamous Cell Carcinoma
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Intervention(s)
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Drug: Quercetin (dietary supplement)
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Primary Outcome(s)
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Reduction of buccal micronuclei
[Time Frame: Up to 30 months]
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Secondary ID(s)
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2018-0073
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6353
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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