Protocol summary
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Study aim
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Prevention of acute mucositis due to radiation therapy in patients with head and neck cancer
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Design
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Two arm parallel group randomized clinical trial, Double-blinded
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Patients with head and neck cancer who are supposed to start radiation therapy.
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Main outcome variables
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Radiotherapy Induced mucositis score
General information
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Reason for update
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End of the clinical trial recruitment and follow-up.
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Acronym
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IRCT registration information
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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
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Registration date
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2019-05-12, 1398/02/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-01, 1398/06/10
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Expected recruitment end date
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2020-02-15, 1398/11/26
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Actual recruitment start date
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2019-09-01, 1398/06/10
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Actual recruitment end date
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2020-02-15, 1398/11/26
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Trial completion date
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2020-04-01, 1399/01/13
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Scientific title
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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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Public title
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Effects of mucutin spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer patients
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
44
Actual sample size reached:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-30, 1397/05/08
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Ethics committee reference number
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IR.RBMU.RETECH.REC.1397.277
Health conditions studied
1
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Description of health condition studied
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Oral mucositis
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ICD-10 code
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K12.3
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ICD-10 code description
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Oral mucositis (ulcerative)
Primary outcomes
1
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Description
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Mucositis
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Timepoint
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At the baseline, Weeks 1,2,3,4,5,6,7
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Method of measurement
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Examination of oral cavity
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Demographic data and the result of the clinical trial
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When the data will become available and for how long
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after 6 month
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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After publishing a monochrome article from a clinical trial
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From where data/document is obtainable
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send to researchers
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What processes are involved for a request to access data/document
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Send request via email
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Comments
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