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 (Sumac- Rose water ) and the other group will receive benzydamine hydrochloride spray.
Participants/Inclusion and exclusion criteria
Head and neck cancers and radiation therapy candidates between 18 and 80 Physical and mental ability to participate in the study Good Performance status Antiperspirants, opioids and during the study received previous radiation therapy and a history of chemotherapy in the last six months in the oral and oropharyngeal history of connective tissue diseases such as Sjنgren, rheumatoid arthritis, lupus; Liver and kidney diseases; Major depression; Diseases involving the salivary glands such as diabetes; Diseases that cause dehydration such as chronic diarrhea, weakened immune system diseases, myelosuppression, diseases that cause mouth sores. Candidiasis and oral herpes Treatment failure, need for intravenous feeding (TPN) or hospitalization before reaching a dose of 50 Gy
Intervention groups
Patients with head and neck cancer for whom radiation therapy is to be started.
The control group receives benzidamine spray
and the experimental group receives sumac spray
Main outcome variables
Mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030467N2
Registration date:2022-01-26, 1400/11/06
Registration timing:prospective
Last update:2022-01-26, 1400/11/06
Update count:0
Registration date
2022-01-26, 1400/11/06
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
2022-02-04, 1400/11/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Sumac spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer
Public title
Effects of Sumac spray and Benzydamine Hydrochloride spray on prevention of radiation induced acute mucositis in head and neck cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Head and neck cancer patient
Candidate for radiation therapy
At least 2 regions of the studied areas in terms of mucositis (based on the mucositis scale) be in the field of radiation therapy
Good performance status with ECOG questionnaire
between 18 to 80
Willingness to participate in the study
Physical and mental ability to cooperate in filling in the questionnaire
Exclusion criteria:
Mucositis grade 3 and 4
History of chemotherapy and radiation therapy in mouth or pharynx in recent six months
Pregnancy
use of artificial saliva
use of mouthwashes
Candidiasis
Having oral herpes
alcohol consumption
smoking
Consumption of drugs affecting salivary glands such as antidepressants, opioids, anti-hypertensives, antihistamines
Diuretic use
Suffering from diseases of the weakened immune system
Dehydration-causing diseases such as chronic diarrhea
Diseases that cause recurrent oral plague
History of connective tissue diseases such as Sogrene, rheumatoid arthritis, lupus
liver and kidney disease
major depression
diseases involving salivary glands such as diabetes
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Not randomized
Randomization description
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
2021-08-15, 1400/05/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.302
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 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: 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
Placebo
2
Description
Intervention group: 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
Nezamabad
City
Tehran
Province
Tehran
Postal code
0000000000000
Phone
+98 21 7343 3000
Email
info@ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mojgan Tansaz
Street address
No. 8, Shams street, Valiasr street
City
Teharan
Province
Tehran
Postal code
1516744511
Phone
+98 21 8877 6027
Email
tansaz_mojgan@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams street, Valiasr street.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
ghazalrad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ghazaleh Heydarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 8, shams street, Valiasr street
City
tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
dr.ghazalrad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
sanaz poshtmahi
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
No 8, Shams St., Valiasr St.
City
tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 6027
Email
ph.sanazy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD