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
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
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030467N1
Registration date:2019-05-12, 1398/02/22
Registration timing:retrospective
Last update:2019-05-12, 1398/02/22
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
2018-07-31, 1397/05/09
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Double blinded
Blinding description
The spray glass has already been filled in and not labeled on the label
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, Daneshju Blv.
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
Shohada Tajrish hospital and Imam Hossein Hospital
Full name of responsible person
Ahmad Ameri
Street address
Tajrish Square, Shohada Tejarish Hospital and Imam Hossein Hospital, Shahid Madani St., Nezam Abad, Tehran