48 Participants Needed

Quercetin for Squamous Cell Cancer in Fanconi Anemia

SA
Overseen ByStephanie A Edwards, BSN, RN
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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.

What evidence supports the effectiveness of the drug Quercetin for treating squamous cell cancer in Fanconi Anemia?

Research indicates that Quercetin, a natural compound found in many plants, has potential anti-cancer properties, including the ability to inhibit tumor growth and regulate cell cycles. Although more research is needed, preliminary studies suggest it may help in reducing cancer cell proliferation.12345

Is quercetin safe for human use?

The research does not provide specific safety data for quercetin in humans, but it suggests that flavonoids, including quercetin, have been studied for their effects on cancer cells. These studies focus on their potential anti-cancer properties rather than safety in humans.12467

What makes quercetin unique as a treatment for squamous cell cancer in Fanconi Anemia?

Quercetin is unique because it is a natural compound with antioxidant and anti-inflammatory properties that can inhibit the growth of certain cancer cells. It works by blocking substances involved in cell proliferation and inflammation, and its effectiveness is enhanced when combined with ascorbic acid, which protects it from oxidative degradation.5891011

What is the purpose of this trial?

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). Improved transplant outcomes are modifying the natural history of Fanconi Anemia. Improved transplant survival, no radiation exposure, and almost no GVHD increases the importance of addressing later SCC even further. 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.Funding Source - FDA Office of Orphan Products Development (OOPD)

Research Team

Parinda A. Mehta, MD

Parinda A Mehta, MD

Principal Investigator

Cincinnati Children's Hosptial Medical Center

Eligibility Criteria

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.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: QuercetinExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

References

The inhibitory effects of 5-hydroxy-3,6,7,8,3',4'-hexamethoxyflavone on human colon cancer cells. [2022]
2'-Hydroxyflavanone: A novel strategy for targeting breast cancer. [2023]
Antioxidants and cancer, part 3: quercetin. [2022]
Antiproliferative activity of flavonoids on several cancer cell lines. [2022]
Effects of several flavonoids on the growth of B16F10 and SK-MEL-1 melanoma cell lines: relationship between structure and activity. [2019]
Flavonoids Isolated from Korea Citrus aurantium L. Induce G2/M Phase Arrest and Apoptosis in Human Gastric Cancer AGS Cells. [2021]
Pure total flavonoids from Citrus paradisi Macfad induce leukemia cell apoptosis in vitro. [2018]
Ascorbic acid-enhanced antiproliferative effect of flavonoids on squamous cell carcinoma in vitro. [2019]
Role of quercetin (a natural herbal compound) in allergy and inflammation. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Growth-inhibitory effect of quercetin and presence of type-II estrogen-binding sites in human colon-cancer cell lines and primary colorectal tumors. [2019]
Investigating the effects of quercetin fatty acid esters on apoptosis, mechanical properties, and expression of ERK in melanoma cell line (A375). [2022]
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