Investigating the effect of Doxepin 0.5% mouthwash in comparison with Persica mouthwash on reducing the pain of oral mucositis in patients with head and neck cancer after radiotherapy and chemotherapy
investigation the effect of doxepin 0.5% mouthwash in comparison with persica mouthwash in reducing oral mucositis pain in head and neck cancer patients after radiotherapy and chemotherapy
Design
Double blind randomized clinical trial with parallel groups design of 56 patients.
Settings and conduct
This study was conducted in oncology ward of Shahid Sadoughi Hospital and Shahid Ramezanzadeh center in Yazd.The information of patients was recorded. Patients and nurses and researcher were not aware of the type of mouthwash received by patients.The patients were gargle each group of 5 cc of the solution for 1 minute.pain score, burning sensation, taste satisfaction ؛drowsiness and other side effects were recorded before the solution, 5, 15, 30, 60, 120, 240 min and 24 hours later in the Study Information Form . Every patient is allowed to use a mouthwash more than 2 times per day. the patient could use acetaminophen 500 mg (maximum 4 grams daily), not 60 minutes before and after the solution. The pain score was measured based on visual analogue scale
Participants/Inclusion and exclusion criteria
Entry requirements:
Age>18 years old
Patients who received more than 45 gray of radiation and had mucositis and their pain score was more than 4 on the basis of the Visual Analogue Scale
Non-entry conditions:
Sensitivity to TCA
Taking TCA or MAOi in the last 2 weeks
Candidiasis or oral herpes
Open-angle glaucoma untreated
Untreated urination retention in the past 6 weeks
Intervention groups
Group 1: Patients who get Persica mouthwash
Group 2: Patients who get Doxepin rinse
All of the patients use mouthwash to reduce pain.
Main outcome variables
Reduced mucositis pain؛ reduce analgesics use؛ improving the nutritional status of the patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N1
Registration date:2020-03-24, 1399/01/05
Registration timing:retrospective
Last update:2020-03-24, 1399/01/05
Update count:0
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2018-05-05, 1397/02/15
Actual recruitment end date
2019-06-05, 1398/03/15
Trial completion date
2019-06-05, 1398/03/15
Scientific title
Investigating the effect of Doxepin 0.5% mouthwash in comparison with Persica mouthwash on reducing the pain of oral mucositis in patients with head and neck cancer after radiotherapy and chemotherapy
Public title
Effect of Doxepin rinse and Persica mouthwash in mucositis pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who received more than 45 gray of radiation and had mucositis and their pain score was more than 4 on the basis of the Visual Analogue Scale
Age more than 18 years old
Exclusion criteria:
Sensitivity to TCA drugs
Taking TCA or MAO inhibitors in the last 2 weeks
Candidiasis infection or oral herpes
Untreated open angle glaucoma
Untreated urination retention in the past 6 weeks
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
56
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method was used. Patients were randomly assigned to two groups by using Random.org site
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participants, health care providers, and researcher unaware of the assigned intervention. Patients in both groups received medications in the same package.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi university of medical science
Street address
Shahid Sadoughi university of medical science, Shohadai Gomnam Blvd, Professor Hesabi Blvd
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2017-12-09, 1396/09/18
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.200
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
Reduction patient pain score
Timepoint
5, 15, 30, 60, 120, 240 minutes and 24 hours after applying mouthwash
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Persika Mouthwash, 5 cc, 3 times a day,1minute. Duration of study: 24 hours, manufactured by Poursina
Category
Treatment - Drugs
2
Description
Control group: Doxepine mouthwash 0.5%, 5cc, 3 times a day ,1minute. Duration of study: 24 hours