Trial Outcomes & Findings for Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia (NCT NCT03476330)
NCT ID: NCT03476330
Last Updated: 2026-04-20
Results Overview
Efficacy of Quercetin in reducing buccal micronuclei. A 20% reduction in the average total number of micronuclei will be considered a success of the intervention.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
1 year
Results posted on
2026-04-20
Participant Flow
Participant milestones
| Measure |
Quercetin
All patients will be treated with oral quercetin.
Quercetin (dietary supplement): Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
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|---|---|
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Overall Study
STARTED
|
48
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Overall Study
COMPLETED
|
29
|
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Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Quercetin
All patients will be treated with oral quercetin.
Quercetin (dietary supplement): Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
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|---|---|
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Overall Study
Lost to Follow-up
|
2
|
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Overall Study
Physician Decision
|
2
|
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Overall Study
Withdrawal by Subject
|
15
|
Baseline Characteristics
Quercetin Chemoprevention for Squamous Cell Carcinoma in Patients With Fanconi Anemia
Baseline characteristics by cohort
| Measure |
Quercetin
n=48 Participants
All patients will be treated with oral quercetin.
Quercetin (dietary supplement): Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
|
|---|---|
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Age, Categorical
<=18 years
|
36 Participants
n=129 Participants
|
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Age, Categorical
Between 18 and 65 years
|
12 Participants
n=129 Participants
|
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Age, Categorical
>=65 years
|
0 Participants
n=129 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=129 Participants
|
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Sex: Female, Male
Male
|
24 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
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Race (NIH/OMB)
Black or African American
|
2 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 48 patients were enrolled in the study but 27 patients had analyzable data at 1 year. Non-analyzable data includes patients who did not complete the study through 1 year, 1 year samples were not available, or 1 year samples were not evaluable.
Efficacy of Quercetin in reducing buccal micronuclei. A 20% reduction in the average total number of micronuclei will be considered a success of the intervention.
Outcome measures
| Measure |
Quercetin
n=27 Participants
All patients will be treated with oral quercetin.
Quercetin (dietary supplement): Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
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|---|---|
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Number of Participants With at Least 20% Reduction of Buccal Micronuclei
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13 Participants
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Adverse Events
Quercetin
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quercetin
n=47 participants at risk
All patients will be treated with oral quercetin.
Quercetin (dietary supplement): Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
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|---|---|
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Gastrointestinal disorders
Other: Crohn's disease flare
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
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|
Infections and infestations
Lung infection
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Infections and infestations
Upper respiratory infection
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonthorax
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
Other adverse events
| Measure |
Quercetin
n=47 participants at risk
All patients will be treated with oral quercetin.
Quercetin (dietary supplement): Quercetin will be administered twice daily at an adjusted dose based on weight for a maximum total daily dose of 4000mg/day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day.
|
|---|---|
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Gastrointestinal disorders
Worsening gastritis
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
2/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Hepatobiliary disorders
Other: Biliary dyskinesia
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
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Investigations
Weight Gain
|
12.8%
6/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
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Metabolism and nutrition disorders
Anorexia
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Skin and subcutaneous tissue disorders
Rash maculo (legs)
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular (back)
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/47 • Participants were monitored for up to 30 days following the final dose of quercetin. The timing of the final dose varied based on duration of participation. 17 participants were on study for less than 1 year, the average number of months was 6.8. 31 participants completed 1-year study period. Two of these participants discontinued drug prior to 2-year time point, the average number of months was 17. 29 participants completed the full 2-year study period, the average number of months was 26.6.
48 patients were enrolled but 1 patient did not initiate quercetin so the total at risk is 47.
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Additional Information
Parinda Mehta, MD
Cincinnati Children's Hospital Medical Center
Phone: 513-636-5917
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place