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

Phase 2

Completed

• Conditions: Radiation-induced Mucositis of Oral Mucous Membranes
• Interventions: Drug: propolis

• Registration Number: NCT01375088
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-21
• Last Update Posted: 2012-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
NCI.CTC Scale	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.

Secondary Outcome Measures

Name	Time	Method
hyposalivation scale	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

Trial Locations

Locations (1)

Mashhad University of Medical Science; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of