Effects of mucutin spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer patients: A comparative clinical study
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General information
1
1
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46
46
2018-07-31, 1397/05/09
2019-09-01, 1398/06/10
20182019-0709-3101 00:00:00
2019-03-06, 1397/12/15
2020-02-15, 1398/11/26
20192020-0302-0615 00:00:00
empty
2019-09-01, 1398/06/10
2019-09-01 00:00:00
empty
2020-02-15, 1398/11/26
2020-02-15 00:00:00
empty
2020-04-01, 1399/01/13
2020-04-01 00:00:00
empty
End of the clinical trial recruitment and follow-up.
End of the clinical trial recruitment and follow-up.
empty
پایان مراحل بیمارگیری و پیگیری بیماران.
پایان مراحل بیمارگیری و پیگیری بیماران.
Simple randomization, random number table
The two groups of the trial according to a previous studies and by taking into account two-sided significance level of 0.05 and power of 99%, the sample size is calculated 20 patients in each group. Considering the possibility of failure to follow up and patients’ drop out, in order to increase the power of the study, the sample size is calculated 22 patients in each group to be totally 44 patients. Simple randomization is done by Randomizer software, before starting the trial. Patients who have inclusion criteria, are randomly assigned into one of the two groups: mucutin spray or Benzydamine Hydrochloride spray
Simple randomization is done by Randomizer software, before starting the trial. Patients who have inclusion criteria, are randomly assigned into one of the two groups based on their selected number: mucutin spray or Benzydamine Hydrochloride spray.
The two groups of the trial according to a previous studies and by taking into account two-sided significance level of 0.05 and power of 99%, the sample size is calculated 20 patients in each group. Considering the possibility of failure to follow up and patients’ drop out, in order to increase the power of the study, the sample size is calculated 22 patients in each group to be totally 44 patients.
Simple randomization is done by Randomizer software, randombefore starting the trial. Patients who have inclusion criteria, are randomly assigned into one of the two groups based on their selected number table: mucutin spray or Benzydamine Hydrochloride spray. The two groups of the trial according to a previous studies and by taking into account two-sided significance level of 0.05 and power of 99%, the sample size is calculated 20 patients in each group. Considering the possibility of failure to follow up and patients’ drop out, in order to increase the power of the study, the sample size is calculated 22 patients in each group to be totally 44 patients. Simple randomization is done by Randomizer software, before starting the trial. Patients who have inclusion criteria, are randomly assigned into one of the two groups: mucutin spray or Benzydamine Hydrochloride spray
تصادفی سازی ساده ،جدول اعداد تصادفی
حجم نمونه با استفاده از فرمول آماری که در آن سطح معناداری =α0.05 در نظر گرفته شده است و توان آزمون 0.801-β= در نظر گرفته شد. این حجم نمونه به منظور شناسایی اختلافی به اندازه 4.5d= (در میانگین تعداد گر گرفتگی ها (با توجه به کاهش 50 درصدی در تعداد گرگرفتگی)) با انحراف معیار 6.3s= (به دست آمده از مطالعات پیشین) محاسبه شده است.
تعداد نمونه مورد نیاز در هر گروه 20 نفر به دست آمد که با در نظر گرفتن 10 درصد امکان ریزش، در هر گروه 22 نفر به عنوان نمونه در نظر گرفته خواهد شد. تصادفی سازی نمونه ها به روش تصادفی ساده توسط جدول اعداد تصادفی در مورد بیمارانی که شرایط ورود به مطالعه را دارند، صورت می پذیرد. بدین صورت که بیماران بر حسب تصادف، در یکی از 2 گروه دریافت کننده ی اسپری موکوتین یا گروه اسپری بنزید امین هیدروکلراید قرار میگیرند.
تخصیص تصادفی ساده با استفاده از نرم افزار کامپیوتری قبل از شروع مطالعه مورد استفاده قرار می گیرد. بدین صورت که بیماران دارای شرایط انتخاب، بر حسب عددی که بطور تصادفی انتخاب می شود، در یکی از 2 گروه دریافت کننده ی اسپری موکوتین یا گروه اسپری بنزید امین هیدروکلراید قرار می گیرند.
حجم نمونه با استفاده از فرمول آماری که در آن سطح معناداری =α0.05 در نظر گرفته شده است و توان آزمون 0.801-β= در نظر گرفته شد. این حجم نمونه به منظور شناسایی اختلافی به اندازه 4.5d= (در میانگین تعداد گر گرفتگی ها (با توجه به کاهش 50 درصدی در تعداد گرگرفتگی)) با انحراف معیار 6.3s= (به دست آمده از مطالعات پیشین) محاسبه شده است.
تعداد نمونه مورد نیاز در هر گروه 20 نفر به دست آمد که با در نظر گرفتن 10 درصد امکان ریزش، در هر گروه 22 نفر به عنوان نمونه در نظر گرفته خواهد شد.
تخصیص تصادفی سازی ساده با استفاده از نرم افزار کامپیوتری قبل از شروع مطالعه مورد استفاده قرار می گیرد. بدین صورت که بیماران دارای شرایط انتخاب،جدول اعداد بر حسب عددی که بطور تصادفی انتخاب می شود، در یکی از 2 گروه دریافت کننده ی اسپری موکوتین یا گروه اسپری بنزید امین هیدروکلراید قرار می گیرند. حجم نمونه با استفاده از فرمول آماری که در آن سطح معناداری =α0.05 در نظر گرفته شده است و توان آزمون 0.801-β= در نظر گرفته شد. این حجم نمونه به منظور شناسایی اختلافی به اندازه 4.5d= (در میانگین تعداد گر گرفتگی ها (با توجه به کاهش 50 درصدی در تعداد گرگرفتگی)) با انحراف معیار 6.3s= (به دست آمده از مطالعات پیشین) محاسبه شده است. تعداد نمونه مورد نیاز در هر گروه 20 نفر به دست آمد که با در نظر گرفتن 10 درصد امکان ریزش، در هر گروه 22 نفر به عنوان نمونه در نظر گرفته خواهد شد. تصادفی سازی نمونه ها به روش تصادفی ساده توسط جدول اعداد تصادفی در مورد بیمارانی که شرایط ورود به مطالعه را دارند، صورت می پذیرد. بدین صورت که بیماران بر حسب تصادف، در یکی از 2 گروه دریافت کننده ی اسپری موکوتین یا گروه اسپری بنزید امین هیدروکلراید قرار میگیرند.
The spray glass has already been filled in and not labeled on the label
Firstly, the protocol would be described to the participants. Then, they will sign written informed consent to start the trial. The investigator is not aware of Groups allocation and will examine and record the patients findings.
Firstly, the protocol would be described to the participants. Then, they will sign written informed consent to start the trial. The spray glass has already been filled ininvestigator is not aware of Groups allocation and not labeled onwill examine and record the labelpatients findings.
شیشه های اسپری از قبل پر شده اند و بر روی لیبل نوع دارو نوشته نشده است
ابتدا نحوه درمان برای شرکت کننده توضیح داده می شود. سپس شرکت کنندگان فرم رضایت آگاهانه را امضا نموده و وارد طرح می شدند. محقق از گروه بیماران مطلع نبوده و درطول دوره درمان، بیماران را معاینه و نتایج را ثبت خواهد کرد.
شیشه های اسپریابتدا نحوه درمان برای شرکت کننده توضیح داده می شود. سپس شرکت کنندگان فرم رضایت آگاهانه را امضا نموده و وارد طرح می شدند. محقق از قبل پر شده اندگروه بیماران مطلع نبوده و بر روی لیبل نوع دارو نوشته نشده استدرطول دوره درمان، بیماران را معاینه و نتایج را ثبت خواهد کرد.
Recruitment centers
#1
Name of recruitment center - English: Shohada Tajrish hospital and Imam Hossein Hospital
Name of recruitment center - Persian: بیمارستان شهدای تجریش و بیمارستان امام حسین (ع)
Full name of responsible person - English: Ahmad Ameri
Full name of responsible person - Persian: دکتر احمد عامری
Street address - English: Tajrish Square, Shohada Tejarish Hospital and Imam Hossein Hospital, Shahid Madani St., Nezam Abad, Tehran
Street address - Persian: ميدان تجريش، بيــمارستان شهداي تجريش و نظام آباد، خ شهید مدنی، بیمارستان امام حسین (ع)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1617763141
Phone: +98 21 2274 9201
Fax:
Email: aham47@yahoo.com
Web page address:
Name of recruitment center - English: Imam Hossein Hospital
Name of recruitment center - Persian: بیمارستان امام حسین (ع)
Full name of responsible person - English: Ahmad Ameri
Full name of responsible person - Persian: دکتر احمد عامری
Street address - English: Imam Hossein Hospital, Shahid Madani St., Nezam Abad, Tehran
Street address - Persian: نظام آباد، خ شهید مدنی، بیمارستان امام حسین (ع)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1617763141
Phone: +98 21 2274 9201
Fax:
Email: aham47@yahoo.com
Web page address:
Name of recruitment center - English: Shohada Tajrish hospital and Imam Hossein Hospital Name of recruitment center - Persian: بیمارستان شهدای تجریش و بیمارستان امام حسین (ع) Full name of responsible person - English: Ahmad Ameri Full name of responsible person - Persian: دکتر احمد عامری Street address - English: Tajrish Square, Shohada Tejarish Hospital and Imam Hossein Hospital, Shahid Madani St., Nezam Abad, Tehran Street address - Persian: ميدان تجريش، بيــمارستان شهداي تجريش و نظام آباد، خ شهید مدنی، بیمارستان امام حسین (ع) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1617763141 Phone: +98 21 2274 9201 Fax: Email: aham47@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Somayeh Esmaeili
Full name of responsible person - Persian: دکتر سمیه اسماعیلی
Street address - English: Shams St., Valiasr St., Shahid Beheshti University of Medical Sciences
Street address - Persian: خیابان شمس، خیابان ولی عصر، دانشگاه علوم پزشکی شهید بهشتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1516745811
Phone: +98 21 8877 6027
Fax:
Email: sesmaeili@sbmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Somayeh Esmaeili
Full name of responsible person - Persian: دکتر سمیه اسماعیلی
Street address - English: No. 8, Shams street, Valiasr street
Street address - Persian: خیابان ولی عصر، خیابان شمس، پلاک 8
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1516745811
Phone: +98 21 8877 6027
Fax:
Email: sesmaeili@sbmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Somayeh Esmaeili Full name of responsible person - Persian: دکتر سمیه اسماعیلی Street address - English: No. 8, Shams St.street, Valiasr St., Shahid Beheshti University of Medical Sciencesstreet Street address - Persian: خیابان شمس، خیابان ولی عصر، دانشگاه علوم پزشکی شهید بهشتیخیابان شمس، پلاک 8 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1516745811 Phone: +98 21 8877 6027 Fax: Email: sesmaeili@sbmu.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sanaz Poshtmahi
Full name of responsible person - Persian: ساناز پشت ماهی
Position - English: student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 67
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 8, Shams street, Valiasr street
Street address - Persian: خیابان ولیعصر، خیابان شمس، پلاک 8
City - English: tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1516745811
Phone: +98 21 8877 6027
Mobile: +98 919 178 9088
Fax:
Email: ph.sanazy@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sanaz Poshtmahi
Full name of responsible person - Persian: ساناز پشت ماهی
Position - English: Student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 67
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 8, Shams St., Valiasr St.
Street address - Persian: خیابان ولیعصر، خیابان شمس، پلاک 8
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1516745811
Phone: +98 21 8877 6027
Mobile: +98 919 178 9088
Fax:
Email: ph.sanazy@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Sanaz Poshtmahi Full name of responsible person - Persian: ساناز پشت ماهی Position - English: studentStudent Position - Persian: دانشجو Latest degree: master Area of specialty/work: 67 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 8, Shams streetSt., Valiasr streetSt. Street address - Persian: خیابان ولیعصر، خیابان شمس، پلاک 8 City - English: tehranTehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1516745811 Phone: +98 21 8877 6027 Mobile: +98 919 178 9088 Fax: Email: ph.sanazy@gmail.com Web page address:
Protocol summary
Study aim
Prevention of acute mucositis due to radiation therapy in patients with head and neck cancer
Design
Two arm parallel group randomized clinical trial, Double-blinded
Settings and conduct
44 volunteer patients with head and neck cancer aged 18-80 years, referred to Imam Hossein Hospital or Shohada-e-Tajrish Hospital (Tehran), who are expected to undergo radiotherapy, will be included in the study according to entry criteria. Patients will be divided into two groups by simple random method. The first group will receive mocutin spray (lemon-honey spray) and the other group will receive benzydamine hydrochloride spray.
Participants/Inclusion and exclusion criteria
Head and neck cancer and radiotherapy candidate
between 18 and 80 years
Physical and mental ability to work Cooperation
The desire to participate in the study
Good Performance Status by Questionnaire
at least 2 regions of the studied areas in terms of mucositis
Use of alcohol, drugs that affect salivary glands such as antipsychotics, opioid and ... During the study
History of radiation therapy and chemotherapy in oral or pharynx in recent six months
history of connective tissue diseases such as Sogrene, rheumatoid arthritis, lupus; liver and kidney disease; major depression; diseases involving salivary glands such as diabetes; diseases causing dehydration such as chronic diarrhea, immune deficiency disorders, myelosuppression, diseases causing repeated oral aphthous
A sudden change in patient's condition or illness so that the patient's predicted radiation therapy changes before reaching the 50-gram dose.
Mucositis grade 3 and 4
Candidosis and oral herpes
Treatment failure, requiring intravenous nutrition (TPN) or hospitalization before reaching a 50-gram dose
Pregnancy
Intervention groups
Patients with head and neck cancer who are supposed to start radiation therapy.
Main outcome variables
Radiotherapy Induced mucositis score
General information
Reason for update
End of the clinical trial recruitment and follow-up.
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030467N1
Registration date:2019-05-12, 1398/02/22
Registration timing:prospective
Last update:2020-08-07, 1399/05/17
Update count:1
Registration date
2019-05-12, 1398/02/22
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4408 0297
Email address
s.poshtmahi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2020-02-15, 1398/11/26
Actual recruitment start date
2019-09-01, 1398/06/10
Actual recruitment end date
2020-02-15, 1398/11/26
Trial completion date
2020-04-01, 1399/01/13
Scientific title
Effects of mucutin spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer patients: A comparative clinical study
Public title
Effects of mucutin spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Head and neck cancer and radiotherapy candidate
age between 18 to 80
Life expectancy more than a year based on physician or team estimates
Physical and mental ability to cooperate in filling in the questionnaire
desire to participate in the study
Good performance status with ECOG questionnaire
At least 2 regions of the studied areas in terms of mucositis (based on the mucositis scale) be in the field of radiation therapy
Exclusion criteria:
Use of alcohol, drugs that affect salivary glands such as antipsychotics, opioids, antihypertensives, antihistanines, diuretics, mouthwashes and artificial saliva and cigarettes
history of radiation therapy and chemotherapy in mouth or pharynx in recent six months
history of connective tissue diseases such as Sogrene, rheumatoid arthritis, lupus; liver and kidney disease; major depression; diseases involving salivary glands such as diabetes; diseases causing dehydration such as chronic diarrhea, immune deficiency disorders, myelosuppression, diseases causing repeated oral aphthous
Mucositis grade 3 and 4
Candidosis or oral herpes
Pregnancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
44
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done by Randomizer software, before starting the trial. Patients who have inclusion criteria, are randomly assigned into one of the two groups based on their selected number: mucutin spray or Benzydamine Hydrochloride spray.
The two groups of the trial according to a previous studies and by taking into account two-sided significance level of 0.05 and power of 99%, the sample size is calculated 20 patients in each group. Considering the possibility of failure to follow up and patients’ drop out, in order to increase the power of the study, the sample size is calculated 22 patients in each group to be totally 44 patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Firstly, the protocol would be described to the participants. Then, they will sign written informed consent to start the trial. The investigator is not aware of Groups allocation and will examine and record the patients findings.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Parvaneh St., Yemen St., Shahid Chamran Highway.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2018-07-30, 1397/05/08
Ethics committee reference number
IR.RBMU.RETECH.REC.1397.277
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
Mucositis
Timepoint
At the baseline, Weeks 1,2,3,4,5,6,7
Method of measurement
Examination of oral cavity
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Mucutin spray group who use the spray 4-8 times per day from a day before the start of radiotherapy up to two weeks of end of radiotherapy or until leaving the study for any reason.
Category
Prevention
2
Description
Intervention group 2: benzydamine hydrochloride spray group who use the spray 4-8 times per day from a day before the start of radiotherapy up to two weeks of end of radiotherapy or until leaving the study for any reason.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Ahmad Ameri
Street address
Imam Hossein Hospital, Shahid Madani St., Nezam Abad, Tehran