Evaluation of the effect of Mucosamin in treatment of radiation induced oral cavity mucositis during and after radiotherapy، in patient with oral cavity squamous cell carcinoma (SCC)
Evaluation of the effect of Mucosamin in the treatment of oral cavity mucositis during and after radiotherapy in patients with oral cavity squamous cell carcinoma
Design
This study is a phase II randomized clinical trial. Participants were randomly divided into two groups according to the random number table: intervention group = 40 people; control group = 40 people
Settings and conduct
This study will be conducted after approval by the ethics committee of Shiraz University of Medical Sciences and all patient information will remain confidential. The checklist will include demographic information (age, sex), complete medical and surgical history, physical examination, and clinical condition.
Patients with oral cavity squamous cell carcinoma with pathologic diagnosis are exposed to radiation of at least 6000 cGy. Oral mucositis and pain severity are recorded weekly during treatment and in the first and second weeks after radiation therapy.
The phone number and address of all patients will be obtained to contact them if they do not visit for follow-up.
Participants/Inclusion and exclusion criteria
Inclusion criteria include people aged 18-75 years; patients with non-metastatic oral cavity squamous cell carcinoma with oral mucositis induced by radiation; performance status <= 2.
Exclusion criteria include people younger than 18 or over 75 years; patients with systemic disease affecting wound healing (diabetes); muco-cutaneous diseases; poor oral hygiene; previous head and neck surgery; radiotherapy and chemotherapy due to malignancy; distant metastases at the time of diagnosis.
Intervention groups
Intervention group: taking Mucosamin spray for 3-4 times a day; Control group: taking the mixing aluminum or magnesium hydroxide, diphenhydramine and nystatin 3 times a day.
Main outcome variables
Oral mucositis; severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190511043551N1
Registration date:2019-10-16, 1398/07/24
Registration timing:registered_while_recruiting
Last update:2019-10-16, 1398/07/24
Update count:0
Registration date
2019-10-16, 1398/07/24
Registrant information
Name
Saeedeh Khaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3224 1316
Email address
khaki@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Mucosamin in treatment of radiation induced oral cavity mucositis during and after radiotherapy، in patient with oral cavity squamous cell carcinoma (SCC)
Public title
Mucosamin in treatment of oral cavity mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-metastatic oral cavity squamous cell carcinoma with oral mucositis induced by radiation
People aged 18-75 years
Exclusion criteria:
Patients with systemic disease which impairs wound healing (diabetes)
Muco-cutaneous disease
Poor oral hygiene
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, subjects will be randomly assigned to one of two intervention and control groups using the random number table. There are no prerequisites for assigning individuals to groups. The randomization unit is individual. Each participant will have an equal chance of being placed in each group.
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Faculty of medicine, Zand avenue
City
Shiraz
Province
Fars
Postal code
71937-11351
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.SUMS.MED.REC.1397.473
Health conditions studied
1
Description of health condition studied
Radiation-induced Mucositis in patients with Oral cavity Squamous Cell Carcinoma
ICD-10 code
C00-C14
ICD-10 code description
Malignant neoplasms of lip, oral cavity and pharynx
Primary outcomes
1
Description
The degree of oral cavity mucositis induced by Radiotherapy
Timepoint
Oral cavity examination weekly from the first week of radiotherapy to two weeks after the radiotherapy
Method of measurement
Oral Mucositis Oncology Radiotherapy Group Scoring Table
Secondary outcomes
1
Description
Severity of pain
Timepoint
Weekly patient visit from the first week of radiotherapy to two weeks after the radiotherapy
Method of measurement
Patient's history and complaint
Intervention groups
1
Description
Intervention group: taking mucosamin spray for 3-4 times/day
Category
Treatment - Drugs
2
Description
Control group: taking standard treatment (magnesium- aluminium-hydroxide, diphenhydramine and nystatin) for 3 times/day
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The checklist will include demographic information (age, sex), complete medical and surgical history, physical examination, and clinical disease conditions for each patient. The oral mucositis oncology radiotherapy scoring table will be filled for each patient. At the end of the study this information can be shared
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academia and people in the industry.
Under which criteria data/document could be used
To continue investigations in this field and similar fields by other researchers and
For comparison as a control group in similar studies
From where data/document is obtainable
saeede_khaki@yahoo.com
Saeedeh Khaki
Namazi Hospital, Shiraz, Radiotherapy Department
07136125367
What processes are involved for a request to access data/document
Send the research project to the following email address
saeede_khaki@yahoo.com