Quercetin for Squamous Cell Cancer in Fanconi Anemia

Overseen By Stephanie A Edwards, BSN, RN

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Digoxin, Quercetin, Antioxidants, others

Disqualifiers: Renal failure, Pregnancy, Radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 30 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether quercetin, a plant compound in many fruits, can prevent or delay squamous cell carcinoma (a type of skin cancer) in people with Fanconi anemia. Fanconi anemia can cause bone marrow failure and increase cancer risk. The trial aims to determine if quercetin can reduce the need for more intense treatments like chemotherapy or radiation. People with Fanconi anemia who can take oral medication might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that patients stop taking digoxin unless they cannot do so for medical reasons. If you are on digoxin and cannot stop, you may not be eligible to participate.

Is there any evidence suggesting that quercetin is likely to be safe for humans?

Research has shown that quercetin is generally safe for people. In a past study, quercetin was safe and well-tolerated by patients with Fanconi anemia. This study aimed to find the right dose and found that participants did not experience major side effects. As a natural antioxidant, quercetin can help protect cells from damage. Although no serious side effects were reported, staying informed and consulting a healthcare provider about any concerns is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for squamous cell cancer in Fanconi anemia?

Unlike the standard treatments for squamous cell cancer in patients with Fanconi anemia, which often involve surgery, radiation, or chemotherapy, quercetin is unique because it is derived from plants and acts as a natural antioxidant. Researchers are excited about quercetin because it targets oxidative stress, which is particularly relevant for patients with Fanconi anemia, who are more susceptible to DNA damage. This treatment offers a potentially less toxic alternative, aiming to reduce cancer progression while minimizing the harsh side effects associated with conventional therapies.

What evidence suggests that quercetin might be an effective treatment for squamous cell cancer in Fanconi anemia?

Research shows that quercetin, a natural antioxidant, might help treat squamous cell carcinoma (SCC) in people with Fanconi anemia. Studies have found that quercetin can alter cancer cells, making them weaker and more likely to die. Lab and animal studies demonstrated that quercetin kills SCC cells. Earlier research indicated that quercetin was safe and well-tolerated by patients with Fanconi anemia. Based on these findings, quercetin might help prevent or delay SCC in this group, possibly reducing the need for more aggressive treatments like chemotherapy or radiation. ^{4 6 7 8 9}

Who Is on the Research Team?

Parinda A Mehta, MD

Principal Investigator

Cincinnati Children's Hosptial Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 2 years old or older.

I can take medicine by mouth.

I have been diagnosed with Fanconi anemia.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral quercetin to prevent or delay the development of squamous cell carcinoma

30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quercetin

Trial Overview 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.

How Is the Trial Designed?

Group I: Quercetin Experimental Treatment 1 Intervention

All patients will be treated with oral quercetin.

Quercetin is already approved in United States for the following indications:

Approved in United States as Quercetin for:

• Herbal Supplementation
• Nonbacterial Chronic Prostatitis
• Interstitial Cystitis

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12008688/

Phase 1 study of quercetin, a natural antioxidant for ... In this dose-finding phase 1 study, quercetin, a natural antioxidant was found to be safe and well tolerated in patients with FA.

2. fanconi.org fanconi.org/supported-researches/quercetin-chemoprevention-for-squamous-cell-carcinoma-in-patients-with-fanconi-anemia/

Quercetin chemoprevention for Squamous cell carcinoma ... This study will confirm a simple and feasible approach for the prevention of SCC with use of oral quercetin.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8771640/

Quercetin induces tongue squamous cell carcinoma ... The results revealed that quercetin induced morphological alterations and decreased the viability of SAS cells. Quercetin also increased apoptosis-related ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/2802040/

The effects of the bioflavonoid quercetin on squamous cell ... Quercetin appears to possess a cytotoxic effect on squamous cell carcinoma of head and neck origin both in vivo and in vitro.

5. mdpi.com mdpi.com/2072-6694/17/18/3046

Head and Neck Cancer in Fanconi Anemia: Clinical ... Individuals with FA have an exquisitely increased risk of head and neck squamous cell carcinoma [5,6,7], here termed FA HNSCC. While FA is a rare genetic ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT03476330?term=quercitin&cond=cancer&

Quercetin Chemoprevention for Squamous Cell Carcinoma ... Active, not recruiting. Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia. ClinicalTrials.gov ID NCT03476330.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03476330/quercetin-chemoprevention-for-squamous-cell-carcinoma-in-patients-with-fanconi-anemia

Quercetin Chemoprevention for Squamous Cell Carcinoma ... Improved transplant outcomes are modifying the natural history of Fanconi Anemia. Improved transplant survival, no radiation exposure, and ...

8. ashpublications.org ashpublications.org/bloodadvances/article/9/8/1927/535168/Phase-1-study-of-quercetin-a-natural-antioxidant

Phase 1 study of quercetin, a natural antioxidant for children ... In this dose-finding phase 1 study, quercetin, a natural antioxidant was found to be safe and well tolerated in patients with FA.

9. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT03476330?keyword=%22Fanconi%20Anemia%22

Quercetin Chemoprevention for Squamous Cell Carcinoma ... The investigators hypothesize that quercetin will prevent or delay the development of SCC and associated complications, there by ameliorating or delaying the ...