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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01375088
Other study ID # 339888
Secondary ID
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


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