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

Radiation-induced Mucositis of Oral Mucous Membranes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375088
• Other study ID #: 339888
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2011
• Last updated: November 21, 2012
• Start date: October 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2012
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Radiation-induced Mucositis of Oral Mucous Membranes

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad University of Medical Science	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NCI.CTC Scale	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	No
Secondary	hyposalivation scale	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	No