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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 29, 2014