NCT01732393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

November 19, 2012

Last Update Submit

December 4, 2012

Conditions

Chemotherapy Induced Oral Mucositis

Keywords

QuercetinChemotherapyMucositisHematologic Malignancies

Outcome Measures

Primary Outcomes (1)

  • lower grade of mucositis

    grade of mucositis due to WHO criteria

    3 weeks

Secondary Outcomes (1)

  • duration of mucositis

    3 weeks of study tiem span and after trial

Study Arms (2)

oral quercetin capsules

ACTIVE COMPARATOR

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

Drug: oral quercetin capsules

oral placebo capsules

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

oral quercetin capsulesDRUG

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 quercetin capsules
PlaceboDRUG
oral placebo capsules

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patient under chemotherapy
  • for a hematologic malignancy
  • the hematologist permits the trial on the patient
  • agreement of patient for participating in the trial

You may not qualify if:

  • presence pf ANY oral lesion at the beginning of the trial
  • loss of follow up
  • use of digoxin and cyclosporine
  • patient death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral Medicine Department of Mashhad dental School

Mashhad, Khorasan Razavi, 91735-498, Iran

Location

MeSH Terms

Conditions

MucositisHematologic Neoplasms

Interventions

Quercetin

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pegah Mosannen Mozafari, assistant professor

    Mashhad University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of oral medicine

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

January 1, 2010

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

IR(1)