Effect of Quercetin in Prevention and Treatment of Oral Mucositis

NCT ID: NCT01732393

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chemotherapy Induced Oral Mucositis

Keywords

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Quercetin Chemotherapy Mucositis Hematologic Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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oral quercetin capsules

Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks

Group Type ACTIVE_COMPARATOR

oral quercetin capsules

Intervention Type DRUG

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.

oral placebo capsules

Patients in the placebo group received two placebo capsules containing lactose .

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Pegah Mosannen Mozafari

assistant professor of oral medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pegah Mosannen Mozafari, assistant professor

Role: STUDY_DIRECTOR

Mashhad University of Medical Sciences

Locations

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Oral Medicine Department of Mashhad dental School

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Other Identifiers

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89470

Identifier Type: -

Identifier Source: org_study_id