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Evaluation of the effectiveness of N-Acetyl Cysteine mouthwash in preventing the occurrence of chemotherapy-induced oral mucositis in cancer patients referred to Imam Khomeini Hospital in Sari

Protocol summary

Study aim
Determining the effectiveness of N-Acetyl cysteine (NAC) mouthwash in preventing mucositis caused by head and neck chemotherapy
Design
Two arm parallel group randomised trial with blinded outcome assessment. Phase2 on 68 patients, Randomisation will be done through the following site. www.sealedenvelope.com/simple-randomiser/v1/lists
Settings and conduct
Mazandaran Faculty of Pharmacy Laboratory, Oncology Department of Imam Khomeini Hospital Mouthwash in similar containers prepared with special codes by the pharmacy department of the Faculty of Pharmacy and provided to patients, and the examiner and the patient do not know the type of mouthwash. Mouthwashes are given to two groups by a final year dental student, and the examination is done by a person who is a specialist in oral diseases and does not know about the groupings and type of mouthwash.
Participants/Inclusion and exclusion criteria
Entry criteria: full alertness, reading and writing literacy, oral mucosa health Exclusion criteria: suffering from respiratory diseases, asthma, diabetes and autoimmune diseases Continuous use of painkillers, narcotics, alcohol, cigarettes, antibiotics and mouthwash solution
Intervention groups
The intervention group consisted of 34 patients who used N-acetylcysteine ​​mouthwash in the amount of 15 ml twice a day for 30 seconds, and the control group included 34 patients who used the placebo mouthwash in the amount of 15 ml twice a day. It is 14 days to complete the study.
Main outcome variables
Intensity of Mucositis, Sex, Age, Mouthwash

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220712055439N1
Registration date: 2022-08-03, 1401/05/12
Registration timing: registered_while_recruiting

Last update: 2022-08-03, 1401/05/12
Update count: 0
Registration date
2022-08-03, 1401/05/12
Registrant information
Name
Anahita Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 3409
Email address
anahita1802@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of N-Acetyl Cysteine mouthwash in preventing the occurrence of chemotherapy-induced oral mucositis in cancer patients referred to Imam Khomeini Hospital in Sari
Public title
Evaluation of N-Acetyl Cysteine mouthwash in preventing the occurrence of chemotherapy-induced oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer patients undergoing chemotherapy for the first time Patients who do not have other systemic diseases
Exclusion criteria:
Patients who have other systemic diseases Taking antibiotics, drugs, cigarettes and other mouthwashes
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
The random block method will be used to allocate the samples to two groups. Blocks will be considered as 4 blocks. Therefore, 17 blocks are needed to perform this study. Group type selection for each person will be done through the following site. www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
Mouthwash is provided to patients in similar containers with specific codes by the Pharmaceutics Department of the Faculty of Pharmacy, and the examiner, clinical caregivers and the patient do not know the type of mouthwash.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
No. 10, Mahdie 20th Alley, Mahdie St.
City
Sari
Province
Mazandaran
Postal code
4818867479
Approval date
2022-06-07, 1401/03/17
Ethics committee reference number
1401.181

Health conditions studied

1

Description of health condition studied
chemotherapy-induced oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)

Primary outcomes

1

Description
Intensity of Mucositis
Timepoint
During the 14 days of the study (from the first day to the fourteenth day after the start of chemotherapy)
Method of measurement
The oral diseases specialist performs the examination based on the classification of the oral mucositis index and records the results in the classification.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group has 34 people and uses N-acetylcysteine ​​mouthwash in the amount of 15 ml twice a day for 30 seconds for 14 days.
Category
Prevention

2

Description
Control group: The control group also includes 34 patients who use placebo mouthwash in the amount of 15 ml twice a day for 14 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Anahita Ghorbani
Street address
Razi St.
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0670
Fax
+98 11 3336 3754
Email
amir.tasfieh@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnezhad
Street address
Mazandaran University of Medical Sciences, Valie-Asr Boulevard, Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
pebrahimnejad@mazums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Anahita Ghorbani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 10, Mahdie 20th Alley, Mahdie St.
City
Sari
Province
Mazandaran
Postal code
4818867479
Phone
+98 11 3326 3409
Email
anahita1802@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Anahita Ghorbani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 10, Mahdie 20th Alley, Mahdie St.
City
Sari
Province
Mazandaran
Postal code
4818867479
Phone
+98 11 3326 3409
Email
anahita1802@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Anahita Ghorbani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mahdie 20th, Mahdie St.
City
Sari
Province
Mazandaran
Postal code
4818867479
Phone
+98 11 3326 3409
Fax
Email
anahita1802@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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