This is a double-blind randomized controlled clinical trial study.
37 patients with mean age 45 years under radiotherapy in oncology ward of Khoramabad Ashayer Shohada and cancer institute of Imam Khomeini hospital in October2010, to last October, 2011 had been participated in this study. After receiving written informed consent; The examiner evaluated them at the end of second weeks of radiotherapy. Patients were randomly classified into 2 groups: intervention (19 patients) and control (18 patients). The bottles containing 100 cc aqueous Glycyrrhiza extract 50% or placebo was given to every patient and ask them to use 2 cc twice per day for 14 days after starting radiotherapy.The main objective is the effect of liquorice extract on oral mucositis and The secondary objective is the effectiveness on the intensity of burning mouth in cancerous patients under radiotherapy.
Inclusion criteria: Patients should be at least 18 years old; There should be definite diagnosis of head and neck cancer for patients; Radiation therapy dose determined by patient’s radiotherapist should be at least 50 Gy; Patient should have the ability of using extract before every radiotherapy session; At least 50% mouth cavity should be in ray field.
Exclusion criteria: Patients who are now under radiotherapy and or have received every type of treatment for head and neck cancer in recent years. Patients with allergic history to glycyrrhiza. Patients who had every type of mouth problem for example active infection, wound and etc. Patient’s announcement of not cooperating in every step of project.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203012464N4
Registration date:2016-07-01, 1395/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Shamsolmolok Najafi
Name of organization / entity
Faculty od Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 0375
Email address
najafi_sh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
keshavarz street blv, Qods Ave-Central Organization of Tehran University of Medical Sciences - 4th Floor
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Glycyrrhiza glabra extract on oral mucositis of patients under head and neck radiotherapy.
Public title
The effect of aqueous extract of Glycyrrhiza glabra on oral inflammation from radiotherapy .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients should be at least 18 years old; There should be definite diagnosis of head and neck cancer for patients; Radiation therapy dose determined by patient’s radiotherapist should be at least 50 Gy (the average dose that often cause mucositis); Patient should have the ability of using extract before every radiotherapy session; At least 50% mouth cavity should be in ray field (diagnosed by radiotherapy expert).
Exclusion criteria: Patients who are now under radiotherapy for head and neck cancer and or have received every type of treatment and ray therapy for head and neck cancer in recent year. Patients with allergic history to glycyrrhiza. Patients who may show complications to medicine. Patients who couldn’t use aqueous glycyrrhiza extract in their mouth on the base of their verdict or their examiner’s saying.Patients who had every type of mouth problem for example active infection, wound and etc. Before starting radiotherapy. Patient’s announcement of not cooperating in every step of project.
Age
From 18 years old to 149 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Faculty of Dentistry, University of Medical Sciences, Kuy-e-Daneshgah, Ghods St, Enghelab Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-10-22, 1392/07/30
Ethics committee reference number
130.1551.د.92
Health conditions studied
1
Description of health condition studied
head and neck malignancecies
ICD-10 code
C00-C14
ICD-10 code description
Malignant neoplasms of lip, oral cavity and pharynx
2
Description of health condition studied
Mucositis
ICD-10 code
L55-L59
ICD-10 code description
Radiation-related disorders of the skin and subcutaneous tissue
Primary outcomes
1
Description
burning mouth
Timepoint
The first day and at the end of 14
Method of measurement
visual scale
2
Description
Wound size
Timepoint
The first day and at the end of 14
Method of measurement
Scaled graph paper
Secondary outcomes
1
Description
drug interactions with analgesic drugs of patients
Timepoint
1week
Method of measurement
visual scale
2
Description
Licorice sensitivity
Timepoint
14 days
Method of measurement
Observability and Question
Intervention groups
1
Description
The bottles containing 100 cc aqueous Glycyrrhiza extract 50% was given to every patient and ask them to use 2 cc twice per day for 14 days after starting radiotherapy.
Category
Treatment - Drugs
2
Description
The bottles containing 100 cc liquid as placebo was given to every patient and ask them to use 2 cc twice per day for 14 days after starting radiotherapy.