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Effect of Quercetin in Prevention and Treatment of Oral Mucositis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pegah Mosannen Mozafari, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01732393
First received: November 19, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chemotherapy Induced Oral Mucositis
 Drug: oral quercetin capsules
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • lower grade of mucositis [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    grade of mucositis due to WHO criteria


Secondary Outcome Measures:
  • duration of mucositis [ Time Frame: 3 weeks of study tiem span and after trial ] [ Designated as safety issue: No ]
    duration of mucositis due to Who criteria


Enrollment: 20
Study Start Date: January 2010
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral quercetin capsules
Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks
 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 Comparator: oral placebo capsules
Patients in the placebo group received two placebo capsules containing lactose .
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732393

Locations
Iran, Islamic Republic of
Oral Medicine Department of Mashhad dental School
MAshhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-498
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Study Director: Pegah Mosannen Mozafari, assistant professor Mashhad University of Medical Sciences
  More Information

No publications provided

Responsible Party: Pegah Mosannen Mozafari, assistant professor of oral medicine, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01732393     History of Changes
Other Study ID Numbers: 89470
Study First Received: November 19, 2012
Last Updated: December 4, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Mashhad University of Medical Sciences:
Quercetin
Chemotherapy
Mucositis
Hematologic Malignancies

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013