This study will be done to assay the effect of bethanechol on radiation induced xerostomia in patients with head and neck cancer. The study population includes patients with head and neck cancers who are going under treatment with 5000 centigray radiation with accelerator device in Ramezan Zade Radiotherapy Center. The case and control group each consists of 17 patients. We use random-number table for randomization. The control group is educated for massage therapy of salivary glands and adequate hydration. lemon tablets are administrated for them 3 times a day as placebo. For case group addition to above mentioned protocol, tablets of bethanechol 25 miligram, 3 times a day is administrated. Unstimulated whole saliva is measured at 2, 4 and six weeks after initiation of radiotherapy by spitting method. During the study, the patients and nurse who collects saliva are not aware of kind of the drug used so this study is a double-blind one.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061813167N3
Registration date:2014-10-07, 1393/07/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-07, 1393/07/15
Registrant information
Name
Maryam Nourelahi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1725 5873
Email address
m.noorelahi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-07-21, 1393/04/30
Expected recruitment end date
2014-10-10, 1393/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Assessing of effect of bethanechol on radiation induced xerostomia in patients with head and neck cancers
Public title
Effect of bethanechol on xerostomia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with cancers of head and neck region include progressive larynx cancer, progressive hypopharynx cancer and nasopharynx cancer; undergone radiation with 5000 centigray by linear accelerator; using oral protective shield
Exclusion criteria: Cardiovascular diseases; gastrointestinal diseases
Age
From 20 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Squ,Yazd,Iran
City
Yazd
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
17/1/48464/پ
Health conditions studied
1
Description of health condition studied
Cancer of larynx, Hypopharynx, Nasopharynx
ICD-10 code
c11،c13،c3
ICD-10 code description
Malignant neoplasm of larynx, Malignant neoplasm of hypopharynx, Malignant of nasopharynx
Primary outcomes
1
Description
Unstimulated whole saliva
Timepoint
2, 4 and 6 weeks after initiation of radiotherapy
Method of measurement
With mililiter by graduated measuring tube by spitting method
Secondary outcomes
empty
Intervention groups
1
Description
Massage therapy, adequate hydration. Bethanechol tablets 25 miligram are administrated for them 3 times a day
Category
Treatment - Drugs
2
Description
Massage therapy, adequate hydration. Lemon tablets are administrated for them 3 times.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ramezan Zade Radiotheraoy Center of Yazd
Full name of responsible person
Nazila maserat
Street address
Ramezan Zade Radiotheraoy Center, Motahary Street, Yazd,Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Nazila maserat
Street address
Dentistry University, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Mohamadsadegh Alemrajabi
Position
Resident of oral medicine
Other areas of specialty/work
Street address
Dentistry University, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1726 0236
Fax
Email
ms.alemrajabi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Mohamadsadegh Alemrajabi
Position
Resident of oral medicine
Other areas of specialty/work
Street address
Dentistry University, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1726 0236
Fax
Email
ms.alemrajabi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Mohamadsadegh Alemrajabi
Position
Resident of oral medicine
Other areas of specialty/work
Street address
Dentistry University, Dahe Fajr Blvd, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1726 0236
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)