Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000847011
Ethics application status
Approved
Date submitted
1/10/2010
Date registered
8/10/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of honey and chamomile mouth washes in the prevention of head and neck radiotherapy –induced stomatitis
Scientific title
Evaluation of the effects of the honey, chamomile and water in the prevention of head and neck radiotherapy – induced stomatitis in patients with head and neck cancer
Secondary ID [1] 252809 0
Nil
Secondary ID [2] 252841 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck cancer 258313 0
stomatitis 258355 0
Condition category
Condition code
Cancer 258503 258503 0 0
Head and neck
Oral and Gastrointestinal 258536 258536 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 50cc honey(it is natural in The Garmsar City)
Arm 2: 3cc chamomile(made in Barig in factory)
Arm 1 and Arm 2 gurgled with mouthwhash solution 3 times per day for 14 day. This intervention commences on completion of ALL radiotherapy treatment
Intervention code [1] 257330 0
Prevention
Comparator / control treatment
Group control received water mouth wash after radiotherapy 3times per day for 14 days . The water is routine mouth wash in Radiotherapy unit in Shafa hospital
Control group
Active

Outcomes
Primary outcome [1] 259373 0
Decreased risk stomatitis after radiotherapy withWorld Health Organisation ( WHO) scale.
WHO scale= grading scale of 0-4 (0, absent; 1, slight pain, erythema; 2, sore defects, can eat solids; 3, very sore defects, requires liquid diet only; 4, alimentation not possible).
Timepoint [1] 259373 0
Decreased risk of stomatitis on completion of all radiotherapy treatment at 1 day.
Secondary outcome [1] 265891 0
Decreased risk stomatitis after 14 days radiotherapy withWorld Health Organisation ( WHO) scale.
WHO scale= grading scale of 0-4 (0, absent; 1, slight pain, erythema; 2, sore defects, can eat solids; 3, very sore defects, requires liquid diet only; 4, alimentation not possible).
Timepoint [1] 265891 0
Decreased risk of stomatitis on completion of all radiotherapy treatment at 14 days.

Eligibility
Key inclusion criteria
- Participation with a diagnosis of head and neck cancer and willing participate.
- Aged 8 years or more
- Non treat with steroid
- Avoid tobacco, alcohol, smoking, opiate substance

- External beam radiotherapy with dose 180-200 CGY Daily
- Non Leucopenia(White Blood Cell<4000mm^3 )
- Non Leucocytes(White Blood Cell>12000mm^3)
- Non Thrombocytopenia
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non Certain systemic condition such as diabetes, Defect in the immune system, Renal disease, Liver disease, Gastrointestinal Disease, Asthma, Allergic
- Allergic to the mouth wash solution
- Temperature>38.5 degrees celius
- Nausea & Vomiting

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 2946 0
Iran, Islamic Republic Of
State/province [1] 2946 0

Funding & Sponsors
Funding source category [1] 257770 0
University
Name [1] 257770 0
Tehran University of Medical Sciences
Country [1] 257770 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical Siences
Address
Keshavarz BLD, Ghods street, Central building of Tehran University of Medical Sciences, 6th floor
Tehran

Iran, Islamic Republic Of
POST CODE: 1419732171
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256982 0
Hospital
Name [1] 256982 0
Shafa Hospital
Address [1] 256982 0
Nurse BLD,Shafa street,Shafa hospital
Kerman
Iran,Islamic Republic of
Post code:7627844717
Country [1] 256982 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259812 0
Ethical Review Commiitee of Tehran University of Medical Sciences
Ethics committee address [1] 259812 0
Keshavarz BLD, Ghods street, Central building of Tehran University of Medical Sciences, 4th floor
Tehran
Iran, Islamic Republic Of
POST CODE:1419732172
Ethics committee country [1] 259812 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 259812 0
Approval date [1] 259812 0
20/05/2010
Ethics approval number [1] 259812 0
62/130//89S

Summary
Brief summary
The Purpose of this study is to compare two mouthwashes (Honey & Chamomile ) in the prevention of head and neck radiotherapy- induced stomatitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31729 0
Address 31729 0
Country 31729 0
Phone 31729 0
Fax 31729 0
Email 31729 0
Contact person for public queries
Name 14976 0
Shivasadat bassampour
Address 14976 0
Nosrat ST.Tohid SQ, Faculty of Nursing and Midwifery of Tehran University of Medical Sciences
Tehran

Iran, Islamic Republic Of
Post Code:1419733171
Country 14976 0
Iran, Islamic Republic Of
Phone 14976 0
009891223839228
Fax 14976 0
Email 14976 0
[email protected]
Contact person for scientific queries
Name 5904 0
Fatemeh Bahramnezhad
Address 5904 0
Nosrat ST.Tohid SQ, Faculty of Nursing and Midwifery of Tehran University of Medical Sciences
Tehran
Iran, Islamic Republic Of
Post Code:1419733171
Country 5904 0
Iran, Islamic Republic Of
Phone 5904 0
009809133974856
Fax 5904 0
Email 5904 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHoney and radiation-induced stomatitis in patients with head and neck cancer.2015https://dx.doi.org/10.5812/ircmj.19256
N.B. These documents automatically identified may not have been verified by the study sponsor.