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Effect of Quercetin in Prevention and Treatment of Oral Mucositis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732393
First Posted: November 22, 2012
Last Update Posted: December 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pegah Mosannen Mozafari, Mashhad University of Medical Sciences
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias

Further study details as provided by Pegah Mosannen Mozafari, Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • lower grade of mucositis [ Time Frame: 3 weeks ]
    grade of mucositis due to WHO criteria


Secondary Outcome Measures:
  • duration of mucositis [ Time Frame: 3 weeks of study tiem span and after trial ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 19, 2012
First Posted: November 22, 2012
Last Update Posted: December 5, 2012
Last Verified: December 2012

Keywords provided by Pegah Mosannen Mozafari, Mashhad University of Medical Sciences:
Quercetin
Chemotherapy
Mucositis
Hematologic Malignancies

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