The effect of alpha-lipoid acid on saliva rate of the patients underwent radiotherapy of head and neck cancers
Design
A clinical trial with a control group, double-blind, randomized, phase3 on 30 patients, was used to randomize the design of six random blocks and using Excel software.
Settings and conduct
The number of 30 patients with various head and neck cancers
. Randomly dividing patients into two groups of 15 intervention (alphalipoic acid) and control group
Examination on the first day before radiotherapy and 2-6-8-12 weeks after radiotherapy
Examinations include checking the amount of unstimulated saliva and collecting saliva in falcon tubes within 5 minutes.
Sampling in Tajrish Martyrs Hospital.
double blind
Participants/Inclusion and exclusion criteria
over 18 years old and suffering from head and neck cancers with a total radiation dose of 56-70 Gy.
Conditions of non-entry: history of liver disease, diabetes, thyroid, history of alcohol consumption, malnutrition, receiving any chemotherapy drugs, people who have had salivary gland cancer, treated with consumption of iron products and pregnant or lactating women
Intervention groups
examined on the first day and before and in 2-6-8-12 weeks after radiotherapy. Examinations on the first day will include measuring the amount of unstimulated saliva and collecting it within 5 minutes. . In this session, ALA capsules or placebo are provided to the patients of two groups to consume before starting radiotherapy.
Alpha lipoic acid 300 mg capsules. The consumption of this capsule is for 3 months, and the patients of this group will consume two Alpic capsules twice a day (morning-evening) each time
Main outcome variables
Prevention of dry mouth and complications related to salivary glands after radiotherapy in head and neck cancer patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221219056864N1
Registration date:2023-07-13, 1402/04/22
Registration timing:prospective
Last update:2023-07-13, 1402/04/22
Update count:0
Registration date
2023-07-13, 1402/04/22
Registrant information
Name
Masume Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8811 5352
Email address
heydari.s370@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation The effect of alpha-lipoid acid on saliva rate of the patients underwent radiotherapy of head and neck cancers
Public title
Investigating the effect of alpha lipoic acid on the amount of saliva in head and neck cancer patients undergoing radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age>18
Patients with head and neck cancers with a total radiation dose of 56-70 Gy
Exclusion criteria:
History of liver disease, diabetes, thyroid
History of alcohol consumption
Malnutrition
Receiving any chemotherapy drugs
History of salivary gland cancer
History of treatment with alpha-lipoid acid for any other reason
History of allergy to alpha-lipoid acid or other antioxidants and food supplements
Consumption of iron products
Pregnant or lactating women
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups of 15 person with intervention (alpha lipoid acid) and control group (placebo). This work was done using the six-person random block design and using Excel software, and it is done in such a way that each person examined in the research is assigned to one of the intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are divided into two groups A and B by the supervisor, and the person who is in charge of examining and delivering the drugs and following up the patients at the same time (resident of oral and maxillofacial diseases) will be unaware of the contents of A and B
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Committee of Biomedical Research Ethics in Dental Sciences
Street address
Valenjak Blvd. Student of Shahid Beheshti Dental Faculty
City
tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.SBMU.RDC.REC.1401.062
Health conditions studied
1
Description of health condition studied
Cancer patients undergoing cervical radiotherapy
ICD-10 code
2
ICD-10 code description
نئوبلاسم
Primary outcomes
1
Description
The effect of alpha-boic acid on the amount of saliva in cancer patients undergoing head and neck radiotherapy
Timepoint
Before starting radiotherapy and 2-6-8-12 weeks after radiotherapy
Method of measurement
Collection of unstimulated saliva in the Falcon tube within 5 minutes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients using 300 mg alpha-phaliboic acid capsules under the name of Elbik by Raha Pharmaceutical Company twice a day for three months, and the control group of patients using placebo with the same form and the same way of administration as the original drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish Martyrs Hospital, Department of Radio-oncology
Full name of responsible person
HEIDARI MASSUME
Street address
میدان تجریش بیمارستان شهدای تجریش کد بستی1989934148
City
TEHRAN
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr-shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
FARID Akhavan GHOLAM REZA
Street address
Isfahan - km 7 of Shiraz Road - Safeh Industrial Town - Unit 11
City
ESFAHAN
Province
Isfehan
Postal code
81791-35148
Phone
+98 31 3654 0859
Email
marketing@rahapharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Reha Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Heidari Massume
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
oromaxillofacial medicine
Street address
Valenjak Blvd. Student of Shahid Beheshti Dental Faculty
City
tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 7752
Email
heydari.s370@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Heidari Massume
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
oromaxillofacial medicine
Street address
Valenjak Blvd. Student of Shahid Beheshti Dental Faculty
City
tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 7752
Email
heydari.s370@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Heidari Massume
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
oromaxillofacial medicine
Street address
Valenjak Blvd. Student of Shahid Beheshti Dental Faculty
City
tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 7753
Email
heydari.s370@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
We do not publish data
When the data will become available and for how long
After defending the thesis and exposition of the article, we provide access
To whom data/document is available
Not applicable
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
If the article is open access, people can access it by referring to the desired sites
What processes are involved for a request to access data/document