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

November 21, 2012 updated by: ATESSA PAKFETRAT, Mashhad University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Khorasan Razavi
      • Mashhad, Khorasan Razavi, Iran, Islamic Republic of
        • Mashhad University of Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - age >15

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Drug: propolis
15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow
Active Comparator: 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
Drug: propolis
15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NCI.CTC Scale
Time Frame: 9 month
we use NCI-CTC scale for patients in 2 groups to assess effect of propolis mouth wash on prevention and treatment of mucositis in patients under radiotherapy.We measured signs(size and sypmtoms) of mucositis by NCI-CTC scale and also we assessed the onset of the mucositis to describe the prevention efficacy of propolis.
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hyposalivation scale
Time Frame: 9 month
we use a scale for patients in 2 groups to assess effect of propolis maouth wash on subjective xerostomy and signs of candidiasis in patiants under radiotherapy
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Principal Investigator: arghavan tonkaboni, resident, oral medicine dep, dental school, mashhad university of medical science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 339888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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