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Effect of Quercetin in Prevention and Treatment of Oral Mucositis

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ClinicalTrials.gov Identifier: NCT01732393
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Pegah Mosannen Mozafari, Mashhad University of Medical Sciences

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Oral Mucositis Drug: oral quercetin capsules Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Quercetin

Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. duration of mucositis [ Time Frame: 3 weeks of study tiem span and after trial ]
    duration of mucositis due to Who criteria


Eligibility Criteria
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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
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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
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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
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Study Director: Pegah Mosannen Mozafari, assistant professor Mashhad University of Medical Sciences
More Information
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Responsible Party: Pegah Mosannen Mozafari, assistant professor of oral medicine, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01732393    
Other Study ID Numbers: 89470
First Posted: November 22, 2012    Key Record Dates
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:
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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