The purpose of this study is to present an effective treatment with long term results to patients with radiation induced xerostomia .Inclusion criteria is the age over 18 years and radiation with at least 40 gray to at least 3 major salivary glands in head and neck and existence of grade 2 xerostomia,it means they need to drink water for each food swallowing .Exclusion criteria is existence of collagen vascular diseases or recurrence of cancer. The study population are the head and neck cancer patients treated in the radiation oncology clinic of Cancer Institute of Imam Khomeini Hospital. The sample size is 30.This study will assess the efficacy of Modiff versus Placebo on the radiation induced xerostomia. It will take 6 mounths from 22 October 2016 to 19 April 2017.The quality of life of patients and their saliva amount will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092629998N1
Registration date:2016-10-30, 1395/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Saeedeh Archang
Name of organization / entity
Resident
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 2272
Email address
s-archang@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized double blind clinical trial for assessing the effect of Modiff versus placebo on radiation induced xerostomia of head and neck patients.
Public title
Assessment of Modiff effect on xerostomia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias:xerostomia at least grade 2 based on Avraham Eisbruch trial's grading(grade1:no malfunction, grade 2:need to exess fluid to swallow, grade 3: changes in nutririon ,sleep,speech and other activities); taking more than 40gray radition to head and neck to be more than three major salivary glands in the radition field;age of 18 years and older; at least 3 mounths later than the end of the radation.
Exclusion criteria:alcohol and other drugs consumption that affect salivary glands like anti depressant;history of connective tissue and collagen vascular diseases like sjogren, rheumatoid arthritis, lupus;systemic or local reccurents;need to prenteralnutrition hospitalsation.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Research and Study managment of Tehran University of Medical Sciences
Street address
poorsina avenue, 16azar sreete, Tehran University of Medical Science
City
Tehran
Postal code
Approval date
2016-09-24, 1395/07/03
Ethics committee reference number
IR.TUMS.REC.1395.2836
Health conditions studied
1
Description of health condition studied
xerostomia
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion
Primary outcomes
1
Description
saliva amount
Timepoint
3times in 3 mountes intervals
Method of measurement
collecting saliva in 5 mintusein the 1 scaled test tube
2
Description
quality of life
Timepoint
3times in 3 mountes intervals
Method of measurement
questionare
Secondary outcomes
1
Description
constipation
Timepoint
3times in 3 mountes intervals
Method of measurement
questionare
2
Description
skin dryness
Timepoint
3times in 3 mountes intervals
Method of measurement
questionare
3
Description
quality of sleep
Timepoint
3times in 3 mountes intervals
Method of measurement
questionare
Intervention groups
1
Description
intervention group:Modiff drug.the combination of Althea and Plantago psyllium and mallow.5 gram saschet. every 8 houres each saschet dissolve in 1 glass of water .drinl daily for 3mounths
Category
Treatment - Drugs
2
Description
placebo group:each sachet contains 5 gram wheat flour plus food colouring produced by Magnolia company. every 8 houres each saschet dissolve in 1 glass of water .drinl daily for 3mounths
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeyni Hospital
Full name of responsible person
Saeedeh Archang
Street address
Cancer Institute, Imam Khomeini Hospital Complex, Keshavarz boulvar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Salamat negar Hekmat pazhoohan corporation ofof Medical Science Traditional Medical School of Tehran
Full name of responsible person
Hossein Rezaeizade MD
Street address
Growth Center of Traditional Medical School ofTehran University of Medical Sciences, West Jamali avenue, Vafamanesh street, Heravi square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Salamat negar Hekmat pazhoohan corporation ofof Medical Science Traditional Medical School of Tehran
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
Cancer Institue of Imam Khomeyni Hospital Complex
Full name of responsible person
Saeedeh Archang
Position
Resident
Other areas of specialty/work
Street address
Cancer Institue of Imam Khomeyni Hospita Complexl, Keshavarz Boulvar
City
Tehran
Postal code
Phone
+98 21 6119 2585
Fax
Email
saeedeh.archang@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cancer Institue of Imam Khomeyni Hospital Complex
Full name of responsible person
Ali Kazemian MD
Position
Associate Professor
Other areas of specialty/work
Street address
Cancer Institue of Imam Khomeyni Hospita Complex, Keshavarz Boulvar
City
Tehran
Postal code
Phone
+98 21 6119 2585
Fax
Email
drKazemian@gmaile.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Saeedeh Archang
Position
Resident
Other areas of specialty/work
Street address
Cancer Institue of Imam Khomeyni Hospital Complex, Keshavarz Boulvar
City
Tehran
Postal code
Phone
+98 21 6119 2585
Fax
Email
saeedeh.archang@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)