Effect of Quercetin in Prevention and Treatment of Oral Mucositis

Chemotherapy Induced Oral Mucositis Clinical Trial

Official title:

Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732393
• Other study ID #: 89470
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 19, 2012
• Last updated: December 4, 2012
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: December 2012
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• patient under chemotherapy

• for a hematologic malignancy

• the hematologist permits the trial on the patient

• agreement of patient for participating in the trial

Exclusion Criteria:

• presence pf ANY oral lesion at the beginning of the trial

• loss of follow up

• use of digoxin and cyclosporine

• patient death

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy Induced Oral Mucositis
• Mucositis
• Stomatitis

Intervention

Drug:
• oral quercetin capsules
10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.
• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Oral Medicine Department of Mashhad dental School	MAshhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lower grade of mucositis	grade of mucositis due to WHO criteria	3 weeks	No
Secondary	duration of mucositis	duration of mucositis due to Who criteria	3 weeks of study tiem span and after trial	No