The objective of this double-blind interventional, placebo controlled study was to evaluate effect of curcumin oral gel on radiotherapy-induced mucositis in patients with head and neck cancer. 37 patients were divided into two groups by balanced block randomization method to receive curcumin oral gel (intervention group) or placebo (control group). During 8-week period of radiotherapy, all the patients were examined once a week and any erythema, ulcer or mouth burn (VAS) was recorded by a blind examiner. Finally, results were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904064255N1
Registration date:2009-01-20, 1387/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-01-20, 1387/11/01
Registrant information
Name
Armaghan Amirian
Name of organization / entity
Tehran university of medical sciences, Dental school
Country
Iran (Islamic Republic of)
Phone
+98 21 6611 2406
Email address
amansourian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-01-20, 1387/11/01
Expected recruitment end date
2009-04-21, 1388/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of curcumin oral gel (curcuma longa) on radiotherapy-induced mucositis in patients with head and neck cancer
Public title
Evaluating the effect of curcumin oral Gel on radiotherapy-induced mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients older than 18 years, presence of head and neck cancer, minimum dose of radiation therapy 50 gy to induce mucositis, ability to use oral gel before radiotherapy session, signing informed consent
Exclusion criteria: suffering from any kind of oral disease such as active oral infection, ulcer, receiving chemotherapy combined with radiotherapy, inability to use oral gel
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
Vice-chancellor for Research, Tehran University of Medical Sciences, Qods street, Keshavarz Blvd-Tehran,Iran
City
Tehran
Postal code
Approval date
2009-06-22, 1388/04/01
Ethics committee reference number
9170
Health conditions studied
1
Description of health condition studied
oral mucositis (radiotherapy-induced mucositis)
ICD-10 code
K13.7
ICD-10 code description
Other and unspecified lesions of oral mucosa
Primary outcomes
1
Description
erythema
Timepoint
once a week during radiotherapy period
Method of measurement
milimeter
2
Description
oral mucositis grade
Timepoint
once a week during radiotherapy period
Method of measurement
clinical examination
3
Description
mouth burn
Timepoint
once a week during radiotherapy period
Method of measurement
visual analogue scale
4
Description
oral ulcer
Timepoint
once a week during radiotherapy period
Method of measurement
clinical examination
Secondary outcomes
1
Description
side effects
Timepoint
once a week during radiotherapy period
Method of measurement
asking the patient
Intervention groups
1
Description
curcumin oral gel, 3 times a day, each time 5cc, keep in the mouth for a minute
Category
Treatment - Drugs
2
Description
placebo oral gel, 3 times a day, each time 5 cc, keep in mouth for a minute
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital, cancer institute
Full name of responsible person
Armaghan Amirian
Street address
Imam khomeini Hospital, Dr Gharib street,Tohid Sq,Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of medical sciences
Full name of responsible person
Resaerch Departmen
Street address
Vice-chancellor for Research, Tehran University of medical sciences, Qods street, Keshavarz blvd, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of medical sciences, dental school
Full name of responsible person
Dr. Arash Mansourian
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran university of medical sciences, Qods street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6611 2439
Fax
Email
amansourian@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of medical sciences, Dental school
Full name of responsible person
Dr. Arash Mansourian
Position
Assistant professor
Other areas of specialty/work
Street address
Tehran university of medical sciences, Qods street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6611 2439
Fax
Email
amansourian@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Armaghan Amirian
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
armaghan.amirian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)