Evaluation of the efficacy of 15% sucralfate mouth wash in the prevention and treatment of 5-fluorouracil induced oral mucositis in cancer patients in sari city
Oral mucositis is one of the severe side effects of chemotherapeutic agents which limits their use. The aim of this clinical trial is to evaluate the efficacy of sucralfate mouth wash (15 %) in the prophylaxis and treatment of oral mucositis induced by the chemotherapeutic agent 5-fluorouracil. Trial design: prospective, randomized, double-blind, placebo-controlled clinical trial. Inclusion criteria: cancer patients 18-70 years receiving 5-fluorouracil containing chemotherapy. Exclusion criteria: sucralfate intolerance or inappropriate use of the mouth wash.
intervention 1: sucralfate mouth wash four times daily for 1 week. Intervention 2: placebo 4 times daily for 1 week. Intervention 3: sucralfate mouth wash and hydroxyzine syrup 4 times daily for 1 week. Intervention 4: placebo and hydroxyzine syrup 4 times daily for 1 week. Outcomes: 1- oral mucositis, measure: WHO grading system. 2- pain, measure: Visual analogue scale. Measurement time point: every 3 days (days 0 and 3 and 6
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107053014N4
Registration date:2012-04-27, 1391/02/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-27, 1391/02/08
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2011-11-01, 1390/08/10
Expected recruitment end date
2012-06-09, 1391/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of 15% sucralfate mouth wash in the prevention and treatment of 5-fluorouracil induced oral mucositis in cancer patients in sari city
Public title
Evaluation the effect of sucralfate 15% mouthwash for Prevention and treatment mouth sores induced by chemotherapy drugs
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Cancer patients between 18-70 years receiving 5-fluorouracil containing chemotherapy regimens.
Exclusion criteria: Sucralfate intolerance or inappropriate use of the mouth wash
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee , Mazandaran University of Medical Sciences
Street address
Vice chancellor for research , Moalem Squer , Mazandaran University of Medical Sciences
City
Sari
Postal code
Approval date
2011-07-27, 1390/05/05
Ethics committee reference number
25
Health conditions studied
1
Description of health condition studied
5-fluorouracil induced oral mucositis
ICD-10 code
k00-k14
ICD-10 code description
Disease of oral cavity : stomatitis
Primary outcomes
1
Description
Mouth sores
Timepoint
every 3 days
Method of measurement
Use of the WHO table and ruler
Secondary outcomes
1
Description
Pain
Timepoint
Before and after 1 months of intervention
Method of measurement
Visual analoug scale (VAS)
2
Description
Dysphagia to liquids
Timepoint
Before and after 2 months of intervention
Method of measurement
Ask a question
3
Description
Dysphagia to solids
Timepoint
weekly
Method of measurement
Ask a question
4
Description
Bleeding
Timepoint
Before and after 2 months of intervention
Method of measurement
Ask a question
Intervention groups
1
Description
Sucralfate , mouthwash , 15 percent , four times a day for a week
Category
Prevention
2
Description
Placebo mouthwash , 4 times a day for a week
Category
Placebo
3
Description
Sucralfate 15 percent mouth wash plus syrup Hydroxyzine , four times a day until oral wound healing
Category
Treatment - Drugs
4
Description
Syrup Hydroxyzine plus placebo , four times a day until oral wound healing
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialty and subspecialty clinics Tuba
Full name of responsible person
Shahram Ala
Street address
Clinic Tuba, Khazar Squar , Sari , Mazandaran , Iran
City
Sari
2
Recruitment center
Name of recruitment center
Imam Khomeini hospital in Sari
Full name of responsible person
Shahram Ala
Street address
Imam Khomeini Hospital, Amir Mazandarani St., Sari , Mazandaran , Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmadali Enayati
Street address
Vice chancellor of research,Moalem squer, Mazandaran, Sari, Mazandaran University of Medical SciencesMazandaran University of Medical SciencesMazandaran University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
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
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Elham Azhdari
Position
Pharmacy student
Other areas of specialty/work
Street address
Faculty of Pharmacy, 400 Hectari, Jadeh darya, Sari