Oral mucositis is a common complication of many cancer treatments that has an adverse impact on the quality of life of patient. It is characterized by painful erythematous and ulcerative lesions. When Glutamine is administered via oral drug delivery, it can reduce oral mucositis, however, not significant as it has low solubility and absorption. The purpose of this study was to evaluate the local effect of glutamine oral gel in prevention of oral mucositis. A randomized clinical trial was carried out in order to evaluate the effect of glutamine oral gel for prevention of oral mucositis. 50 diagnosed cancer patients were recruited. All patients were on main chemotherapeutic agents which are associated with oral mucositis as a main side effect. Patients were divided into two groups of 25. Group A are patients who are going under chemotherapy treatment with general oral care, group B are patients with similar regimen but supplied with glutamine oral gel. Patients were assessed at baseline and at the end of each cycle using visual examination as well as using the Patient-Reported Oral Mucositis Symptom (PROMS) scale and Oral Mucositis Assessment Scale (OMAS) questionnaires. Patients were followed for a period of three cycles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411153106N19
Registration date:2014-12-12, 1393/09/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-12, 1393/09/21
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, pharmaceutical sciences branch
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Glutamine Oral gel onprevention of chemotherapy-induced mucositis
Public title
The effect of Glutamine Oral gel onprevention of chemotherapy-induced mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: consciousness; being literate; chemotherapeutic management with drugs which induce mucositis; no stomatitis; no oral disease; no renal & liver disorders; no auto immune disease and diabetes; no fever and neutropenia; no recieved antibiotic & narcotic analgesic
Exclusion criterion: sensitivity to glutamine oral gel.
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IAUPS branch of pharmaceutical sciences
Street address
pharmacutical sciences branch,Islamic AZAD university,Yakhchal street,Shariati street
City
Tehran
Postal code
1941933111
Approval date
2013-12-31, 1392/10/10
Ethics committee reference number
4857
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
Mucositis
Timepoint
At the end of cycle for 3 cycles
Method of measurement
PROMS and OMAS questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: general oral care with glutamine oral gel, from the first day up the end of cycle for 3 cycles. Patients were assessed at baseline and at the end of each cycle using visual examination as well as using the Patient-Reported Oral Mucositis Symptom (PROMS) scale and Oral Mucositis Assessment Scale (OMAS) questionnaires
Category
Treatment - Drugs
2
Description
Control group: general oral care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr. Abdolali Shahrasbi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical science branch of Islamic Azad University
Full name of responsible person
Dr. Sepideh Arbabi Bidgoli
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical science branch of Islamic Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical science branch of Islamic Azad university
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant professor / Head of Department
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2246 0056
Fax
Email
mehdirj@aol.co.uk
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)