Study on Quercetin for Preventing Squamous Cell Carcinoma in Patients with Fanconi Anemia

Sponsor: Children's Hospital Medical Center, Cincinnati

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03476330

This clinical trial is exploring whether quercetin, a natural compound, can help prevent or delay squamous cell carcinoma (SCC) in patients with Fanconi Anemia, potentially reducing the need for chemotherapy or radiation.

Patient Parameters

Program Overview

Fanconi Anemia is a genetic condition that can lead to bone marrow failure and increase the risk of certain cancers, like squamous cell carcinoma (SCC). This study is testing if quercetin, a natural substance, can help prevent or delay SCC in people with Fanconi Anemia. By doing so, it might reduce the need for treatments like chemotherapy or radiation, which can have serious side effects. The study is funded by the FDA's Office of Orphan Products Development.

Description

This study focuses on people with Fanconi Anemia, a genetic disorder that can cause bone marrow problems and increase the risk of cancers like squamous cell carcinoma (SCC). The only current cure for the blood-related issues in Fanconi Anemia is a bone marrow transplant. Researchers believe that quercetin, a natural compound, might help prevent or delay SCC and its complications, potentially reducing the need for harsh treatments like chemotherapy or radiation.

The study is open-label, meaning all participants will know they are receiving quercetin. It will include about 45 patients who have had a bone marrow transplant and about 10 who have not. Participants can join whether or not they have had SCC or pre-cancerous lesions, as long as they meet the study criteria and the lead researcher agrees. All participants will take quercetin by mouth.

Researchers will look at how well quercetin works by measuring changes in buccal micronuclei, which are indicators of DNA damage and cancer risk, in patients with Fanconi Anemia who have had a transplant.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Fanconi Anemia
  • Able to take medication by mouth
  • Age 2 years or older

Exclusion Criteria

  • Kidney failure requiring dialysis
  • High bilirubin levels or liver enzyme levels at the start of the study
  • Taking digoxin and unable to stop for medical reasons
  • Pregnant, breastfeeding, or at risk of pregnancy or fathering a child without using birth control during the study
  • Have taken quercetin or other antioxidants in the last 30 days
  • Receiving radiation, chemotherapy, or immunotherapy for SCC

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