Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers

NCT ID: NCT01375088

Last Updated: 2012-11-22

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

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.

Detailed Description

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Patients with head and neck malignancy with inclusion criteria randomly divide in 2 groups and take the intervention.

Conditions

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Radiation-induced Mucositis of Oral Mucous Membranes

Keywords

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propolis mucositis radiotherapy cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo mouth wash

10 patients swish \& swallow 15 ml placebo mouth wash for at least 5 min from the first session of radiotherapy until the last session

Group Type PLACEBO_COMPARATOR

propolis

Intervention Type DRUG

15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow

propolis

10 patients swish \& swallow 15 ml propolis mouth wash for at least 5 min from the first session of radiotherapy until the last session

Group Type ACTIVE_COMPARATOR

propolis

Intervention Type DRUG

15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow

Interventions

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propolis

15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* need of radiotherapy
* at least half of the mouth in the field of radiation
* dose 50 -70 Gy
* head \& neck malignancy

Exclusion Criteria

* systemic disease
* FBS \> 150 WBC \> 3000
* history of radiotherapy
* need of chemotherapy
* systemic disease
Minimum Eligible Age

15 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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ATESSA PAKFETRAT

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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arghavan tonkaboni, resident

Role: PRINCIPAL_INVESTIGATOR

oral medicine dep, dental school, mashhad university of medical science

Locations

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Mashhad University of Medical Science

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Other Identifiers

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339888

Identifier Type: -

Identifier Source: org_study_id