Investigating the role of injection of Botulinum toxin in reserving the function of salivary gland in patients treated with neck radiotherapy
Design
The role of botulinum toxin in prevention of xerostomia will be evaluated in this phase 2 clinical trial. Patients will enter in two groups including intervention (injecting toxin in submandibular gland before neck radiotherapy) and control (neck radiotherapy without further intervention). Xerostomia will be evaluated through scintigraphy before and after neck radiotherapy.
Settings and conduct
This study will be conducted in radiation-oncology ward of Imam Khomeini hospital. Patients who are referred for neck radiotherapy will be entered non randomized in intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age older than 18 years
Exclusion criteria:
History of xerostomia
History of previous neck radiotherapy
History of collagen vascular disease
Intervention groups
Intervention group: patients should be injected by 50 units botulinum toxin (Ipsen) in submandibular salivary gland two weeks before radiotherapy. xerostomia should be evaluated through scintigraphy before and after radiotherapy.
Control group: xerostomia should be evaluated through scintigraphy before and after radiotherapy.
Main outcome variables
Xerostomia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180225038862N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Sepideh Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 6003
Email address
smansouri@ibcrc.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the role of injection of botulinum toxin in reserving the function of salivary gland in patients treated with neck radiotherapy
Public title
Administration of botulinum toxin in reserving the function of salivary gland in neck radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years
Exclusion criteria:
History of xerostomia
History of previous neck radiotherapy
History of collagen vascular disease
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
No 21, Dameshgh St. , Vali - e Asr Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1498789534589
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.TUMS.VCR.REC.1397.043
Health conditions studied
1
Description of health condition studied
Malignant tumors of head and neck
ICD-10 code
C76.0
ICD-10 code description
Malignant neoplasm of head, face and neck
Primary outcomes
1
Description
Xerostomia
Timepoint
Xerostomia will be evaluated before starting radiotherapy and 6 months after finishing radiotherapy.
Method of measurement
Xerostomia will be evaluated through scintigraphy of sub-mandibular gland.
Secondary outcomes
1
Description
Constipation
Timepoint
Constipation will be evaluated before injection of toxin and 6 months after injection.
Method of measurement
Constipation will be evaluated through history.
Intervention groups
1
Description
Intervention group: patients will be injected by 50 units botulinum toxin in submandibular gland before neck radiotherapy.
Category
Treatment - Drugs
2
Description
Control group: patients will be irradiated without any intervention on the submandibular gland.