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Effect of Quercetin in Prevention and Treatment of Oral Mucositis

Primary Purpose

Chemotherapy Induced Oral Mucositis

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

oral quercetin capsules

Placebo

About this trial

This is an interventional treatment trial for Chemotherapy Induced Oral Mucositis focused on measuring Quercetin, Chemotherapy, Mucositis, Hematologic Malignancies

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oral Medicine Department of Mashhad dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

oral quercetin capsules

oral placebo capsules

Arm Description

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 .

Outcomes

Primary Outcome Measures

lower grade of mucositis

grade of mucositis due to WHO criteria

Secondary Outcome Measures

duration of mucositis

duration of mucositis due to Who criteria

Full Information

NCT ID

NCT01732393

First Posted

November 19, 2012

Last Updated

December 4, 2012

Sponsor

Mashhad University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01732393

Brief Title

Effect of Quercetin in Prevention and Treatment of Oral Mucositis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy Induced Oral Mucositis

Keywords

Quercetin, Chemotherapy, Mucositis, Hematologic Malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oral quercetin capsules

Arm Type

Active Comparator

Arm Description

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

Arm Title

oral placebo capsules

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

oral quercetin capsules

Intervention Description

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

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

lower grade of mucositis

Description

grade of mucositis due to WHO criteria

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

duration of mucositis

Description

duration of mucositis due to Who criteria

Time Frame

3 weeks of study tiem span and after trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pegah Mosannen Mozafari, assistant professor

Organizational Affiliation

Mashhad University of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Oral Medicine Department of Mashhad dental School

City

MAshhad

State/Province

Khorasan Razavi

ZIP/Postal Code

91735-498

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Quercetin in Prevention and Treatment of Oral Mucositis

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