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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction of buccal micronuclei
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
815 Previous Clinical Trials
6,530,622 Total Patients Enrolled
9 Trials studying Fanconi Anemia
212 Patients Enrolled for Fanconi Anemia
Parinda A Mehta, MDPrincipal InvestigatorCincinnati Children's Hosptial Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin level is higher than 3 mg/dl, or your SGPT level is higher than 200 at the time of enrolling in the study.I am not pregnant, breastfeeding, or planning to become pregnant, and I can use birth control during the study.I am on dialysis for kidney failure.I haven't taken quercetin or other antioxidants in the last 30 days.I am 2 years old or older.I can take medicine by mouth.I am currently undergoing treatment for squamous cell carcinoma.I have been diagnosed with Fanconi anemia.I am on digoxin and cannot stop it for medical reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Quercetin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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