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Comparison of aloe vera mouthwash and and Benzydamine Hydrochloride mouthwash on radiation induced mucositis in patients with head and neck cancer

Protocol summary

Summary
Study objective: The main objective of the project: Comparative evaluation of the effects of Aloe Vera and Benzydamine HCL mouth rinses on the mucositis caused by radiotherapy in patients with head and neck cancer. The secondary objectives: Effect of Aloe Vera mouth rinse on Mucositis grade, effect of Benzydamine HCL mouth rinse on Mucositis grade, comparing the effects of Aloe Vera and Benzydamine HCL mouth rinses on Mucositis grade- Design of study: randomized, triple blind, without placebo, single-Center, Phase II trial- study population: main inclusion criteria: Minimum age of 18 years, diagnosed cancer in the head and neck region, the minimum therapeutic dose of 50 Gy, oral cavity is placed in the radiation field- main exclusion criteria: history of cancer treatment during last year, history of food allergy, presence of any oral lesions including active infection, oral ulcers before starting radiation therapy- Target sample size: 26 people- study Intervention: Patients are divided into two groups by balanced block randomization. Two types of drugs are being used in this study: 1 - Aloe Vera Mouth rinse (%100) 2 - Benzydamine hydrochloride Mouth rinse(0 .15 % ) (common palliative treatment of mucositis) Patients are asked to use mouthwash , three times daily, during the six weeks period of the Radiotherapy and even one week more after it. To investigate the effects of drugs on the degree of mucositis, the table provided by the World Health Organization (WHO) is used. Expected recruitment start date:10/7/2012- Expected recruitment end date: 9/1/2013- Study primary outcome: Mucositis grade

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012072410377N1
Registration date: 2012-11-16, 1391/08/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-16, 1391/08/26
Registrant information
Name
Mohammad Haji Mirza Mohammad
Name of organization / entity
Oral medicine department, school of Dentistry Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4428 0101
Email address
haji58@yahoo.com
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Company Barij Essence, vice chancellor for research, school of Dentistry Tehran University of Medical Sciences
Expected recruitment start date
2012-07-10, 1391/04/20
Expected recruitment end date
2013-01-09, 1391/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of aloe vera mouthwash and and Benzydamine Hydrochloride mouthwash on radiation induced mucositis in patients with head and neck cancer
Public title
Comparison the effect of Aloe Vera and Benzydamine hydrochloride mouth rinses on mucositis caused by radiation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Minimum age: 18 years, diagnosed cancer in the head and neck region, the minimum therapeutic dose of 50 Gy, oral cavity is placed in the radiation field, the patient's ability to cooperate and use medications as directed. Exclusion criteria: Patients with a history of cancer treatment during the last year, patients with a history of food allergy, oral lesions including active infection, mouth ulcers before starting the radiation therapy, lack of patient willingness and cooperation to participate in the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Process of randomization: Pharmaceutical Company ” Barij Essence” will be packaged the mouth rinses into two quite similar bottles and will be send them to School of Dentistry, Tehran University of Medical Sciences. Two non-beneficiaries will label the bottles and then will give them to the Researcher. Without being aware about the mouth rinses ingredients, and just based on the ordering (numbers) The researcher will give the bottles to the patients. Patients will not aware about the content of the rinses either. In the consent form it is indicated that Rinses contain Benzydamine or Aloe Vera extract. Neither the researcher, nor the patients nor the statistical analyzer will be aware of the type of mouth rinses.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research,Tehran University of Medical Sciences
Street address
The Sixth Floor, central Organization of University, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-07-23, 1391/05/02
Ethics committee reference number
91\ص\926\130

Health conditions studied

1

Description of health condition studied
Mucositis
ICD-10 code
L58.0
ICD-10 code description
Acute radio dermatitis

Primary outcomes

1

Description
Mucositis grade
Timepoint
From Starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment
Method of measurement
questionnaire based on the Mucositis grade rating items from the World Health Organization (WHO)

Secondary outcomes

1

Description
mouth soreness
Timepoint
From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment
Method of measurement
Questionnaire (Asking from patient)

2

Description
Ulcer
Timepoint
From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment
Method of measurement
Questionnaire (Observation)

3

Description
Disability to swallowing solid food
Timepoint
From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment
Method of measurement
Questionnaire (Asking from patient)

4

Description
Disability to alimentation
Timepoint
From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment
Method of measurement
Questionnaire (Asking from patient)

5

Description
Erythema
Timepoint
From starting of radiation therapy, weekly during 6 weeks of treatment and 1 week after treatment
Method of measurement
Questionnaire (Asking from patient and observation)

Intervention groups

1

Description
Intervention: Aloe vera mouth rinse, chemical composition: Aloe vera gel 100%, concentration of 0.0009% Blue color Brilliant Blue, concentration of 0.0006% yellow color Tarterazine, manufacturer: Baryj Essence Pharmaceutical Company- During 6 weeks of Radiotherapy and up to 1 week after it, patients are asked to use 5 cc of mouth rinse 3 times a day, each time for 2 minutes and are avoid from eating and drinking for 30 minutes after using the mouth rinse.
Category
Prevention

2

Description
Control: Benzydamine hydrochloride Mouth rinse, chemical composition: Benzydamine hydrochloride 0/15 %, manufacturer: pharmaceutical company Behvazan, brand: Behvazan 0/15% - During 6 weeks of Radiotherapy and up to 1 week after it, patients are asked to use 5 cc of mouth rinse 3 times a day, each time for 2 minutes and are avoid from eating and drinking for 30 minutes after using the mouth rinse.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini Hospital of Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Kazemian
Street address
Room Number 3, radiotherapy Clinic, cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baryj Essence Pharmaceutical Company
Full name of responsible person
Doctor Mohsen Taghizadeh
Street address
Department of Biochemistry and Nutrition, Kashan University of Medical Sciences, Kashan, I.R.Iran.
City
Kashan
Grant name
Grant code / Reference number
-------------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baryj Essence Pharmaceutical Company
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice chancellor for research, school of Dentistry Tehran University of Medical Sciences
Full name of responsible person
Tahereh Sadat Jafarzadeh Kashi
Street address
Vice chancellor for research, second floor, school of Dentistry Tehran University of Medical Sciences, next to nuclear energy Organization, North kargar Street, Tehran
City
Tehran
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, school of Dentistry Tehran University of Medical Sciences
Proportion provided by this source
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
School of Dentistry Tehran University of Medical Sciences, oral medicine Department
Full name of responsible person
Doctor Arash Mansourian
Position
Associated Professor
Other areas of specialty/work
Street address
Oral Medicine Department, school of Dentistry Tehran University of Medical Sciences، next to nuclear energy organization ، North Kargar Street، Tehran
City
Tehran
Postal code
Phone
+98 21 8835 1152
Fax
Email
aMansourian@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Dentistry Tehran University of Medical Sciences, oral medicine Department
Full name of responsible person
Doctor Mahnaz Saheb Jamee
Position
Professor/DDS.MS
Other areas of specialty/work
Street address
Oral Medicine Department, school of Dentistry Tehran University of Medical Sciences, next to nuclear energy organization , North Kargar Street,Tehran
City
Tehran
Postal code
Phone
+98 21 8835 1152
Fax
Email
sahebjam@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Oral Medicine Department, school of Dentistry Tehran University of Medical Sciences
Full name of responsible person
Mohammad Haji Mirza Mohammad
Position
Resident of oral medicine
Other areas of specialty/work
Street address
First Floor, no. 6, kourosh deadlock, kourosh Alley, Sattar Khan Ave, Tehran
City
Tehran
Postal code
14549
Phone
+98 21 4428 0101
Fax
Email
haji58@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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