The purpose of this study was to evaluate the effects of Iranian propolis on the oral mucositis induced by radiation therapy in patients with oral cancer.
This is a randomized , double-blind , placebo- controlled , single-center , phase one trial. Sixty patient with head and neck malignancy who are referred to Shahid Rajaee Hospital for radiation therapy enter the trial.
Inclusion criteria are: received dose of at least 4000 Gy and being oral cavity in the field of radiation. Exclusive criteria are: presence of any systemic diseases such as diabetes , hypertension , oral active infection , active collagen vascular disease , smoking , presence of any type of allergy and sensitivity to honey and its products , history of radiation therapy to the head and neck area , receiving chemotherapy at the same time and stopping the radiation because of severe mucositits.
The patient should not use honey and wax accidentally during the study. Patients are allocated in two groups of 30 and are matched according to sex and type of cancer. The first group will receive 300 mg propolis 8 times a day since starting radiation. The second group will received placebo 8 times a day since starting radiation.
All patients will visit and evaluate weekly and oral mucositits will record according to WHO and OMAS indices at the end of each week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081018753N1
Registration date:2015-01-23, 1393/11/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-23, 1393/11/03
Registrant information
Name
Mina Motallebnejad
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 111 4191
Email address
m.motallebnejad@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
approved fund by deputy of research & technology of Babol University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Iranian Propolis on Radiation- Induced Mucositis
Public title
The Effect of Iranian Propolis on Radiation- Induced oral ulceration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: oral cancer ; received dose of at least 4000 Gy ; being oral cavity in the field of radiation.
Exclusive criteria are: presence of any systemic diseases such as diabetes , hypertension ; oral active infection ; active collagen vascular disease ; smoking ; presence of any type of allergy ; sensitivity to honey and its products ; history of radiation therapy to the head and neck area ; receiving chemotherapy at the same time ; stopping the radiation because of severe mucositits.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Medical Sciences
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Approval date
2013-12-17, 1392/09/26
Ethics committee reference number
30/3480/ژ/ب
Health conditions studied
1
Description of health condition studied
Mucositis
ICD-10 code
k12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
Mucositis severity
Timepoint
weekly
Method of measurement
By OMAS & WHO indices
Secondary outcomes
empty
Intervention groups
1
Description
Prpolis , Tab 300 mg, oral, 8 times day , 6 weaks
Category
Treatment - Drugs
2
Description
placebo( lactose),Tab 300 mg , 8 times a day ,six weaks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Radio Oncology (Sh R- Hospital)
Full name of responsible person
Dariosh Moslemi
Street address
Shahid Rajai- Hospital, Babolsar
City
Babolsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences- Deputy of research & technology
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fateme Sayyadi
Position
Post graduate student
Other areas of specialty/work
Street address
School of Dentistry, Babol
City
Babol
Postal code
Phone
+98 11 3230 0370
Fax
Email
f.sayyadi90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mina Motallebnejad
Position
Associate
Other areas of specialty/work
Street address
Dental School, Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 112229408
Fax
Email
mmotallebnejad@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)