Effect of Quercetin in Prevention and Treatment of Oral Mucositis

December 4, 2012 updated by: Pegah Mosannen Mozafari, Mashhad University of Medical Sciences

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Khorasan Razavi
      • MAshhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-498
        • Oral Medicine Department of Mashhad dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oral quercetin capsules
Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks
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 Comparator: oral placebo capsules
Patients in the placebo group received two placebo capsules containing lactose .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lower grade of mucositis
Time Frame: 3 weeks
grade of mucositis due to WHO criteria
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of mucositis
Time Frame: 3 weeks of study tiem span and after trial
duration of mucositis due to Who criteria
3 weeks of study tiem span and after trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pegah Mosannen Mozafari, assistant professor, Mashhad University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 22, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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