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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ATESSA PAKFETRAT, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01375088
First received: June 1, 2011
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Radiation-induced Mucositis of Oral Mucous Membranes
Drug: propolis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase I Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • NCI.CTC Scale [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    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:
  • hyposalivation scale [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    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


Enrollment: 20
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375088

Locations
Iran, Islamic Republic of
Mashhad University of Medical Science
Mashhad, Khorasan Razavi, Iran, Islamic Republic of
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Principal Investigator: arghavan tonkaboni, resident oral medicine dep, dental school, mashhad university of medical science
  More Information

No publications provided

Responsible Party: ATESSA PAKFETRAT, Associate professor, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01375088     History of Changes
Other Study ID Numbers: 339888
Study First Received: June 1, 2011
Last Updated: November 21, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:
propolis
mucositis
radiotherapy
cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Propolis
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014