General purpose
Preventive effect of alpha lipoic acid on oral mucositis in patients receiving head and neck radiotherapy
Design
The trial has a control group, with a parallel group, double-blind, randomized, phase 3 on 30 patients. Six random blocks are used for randomization using Excel software.
Settings and conduct
In ShahadaTajrish Hospital,30 cancer patients are undergoing radiotherapy. We give the original and placebo capsules, which are similar and have been coded by the supervisor, to the patients, and we ask them to take them during radiotherapy and up to 2 weeks after completion. use the medicine. The symptoms of mucovites are checked weekly by the resident.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with oral and nasopharyngeal cancer treated with a total dose of 5600-7000 cGy
Exclusion criteria:
Lack of cooperation or willingness of the patient to continue treatment
History of allergies to alpha-lipoic acid or other antioxidants and dietary supplements
Pregnant or lactating women.
Intervention groups
Alpha lipoic acid capsules were given to the intervention group to consume two 300 mg capsules twice a day during the radiotherapy treatment and two weeks after that. And for the control group, placebo capsules are prescribed in the same way. In addition, both groups of patients receive treatment with normal saline mouthwash twice a day during their treatment until two weeks after radiotherapy treatment.
Main outcome variables
Degree of mucositis
General information
Reason for update
Acronym
اثر پیشگیری کننده ALA روی RIOM
IRCT registration information
IRCT registration number:IRCT20220607055099N1
Registration date:2023-07-19, 1402/04/28
Registration timing:prospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Maryam Jarahzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 6086
Email address
maryam.jarahzade92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-21, 1402/04/30
Expected recruitment end date
2024-05-09, 1403/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluaton of prophylactic effect of alpha lipoic acid on oral mucositis in patients undergoing head and neck radiotherapy
Public title
Evaluaton of prophylactic effect of alpha lipoic acid on oral mucositis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with oral and nasopharyngeal cancer treated with a total radiation dose of 5600-7000 cGy
Exclusion criteria:
Pregnant patients
Patients under 18 years old
Patients with diabetes, thyroid disease, and liver disease
Alcohol users
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
15
The intervention and control groups each have 15 patients
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to two groups of 15 intervention (alpha-lipoic acid) and control group (methylcellulose) is based on six random blocks using Excel software.
To obtain the number of samples according to SD1 = 0.13 and SD2 = 0.2 in the study of Kakoie et al. and with α = 0.05, B = 0.1 and power = 80% in order to detect a 0.2 difference between the two groups with a number of 15 samples in each We need a group.
n=(Zα/2+Zβ)2×(SD1 +SD2)2/d2
The assignment of patients to the intervention and control groups is done by randomization, which was explained, so that the patients are not aware of the contents of the given capsule. Due to the similarity between the weight, color, and shape of the drugs, the possibility of informing the patients is minimized. The drugs are divided into two groups A and B by the supervisor, and the person who is in charge of the examination and delivery of the drugs and the follow-up of the patients at the same time (resident of oral, jaw and facial diseases) is unaware of the contents of A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is done in a double blind way. The assignment of patients to the intervention and control groups is done by randomization so that the patients are not aware of the contents of the given capsule. Due to the similarities between the weight, color, and shape of the drugs, the possibility of informing the patients is minimized. The drugs are divided into two groups A and B by the supervisor, and the person who is in charge of the examination and delivery of the drugs and the follow-up of the patients at the same time (resident of oral, jaw and facial diseases) is unaware of the contents of A and B.
Placebo
Used
Assignment
Other
Other design features
The main drug (alphalipoic acid) was given to the intervention group in this study. Placebo was assigned to the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti Research Institute of Dental Sciences
Street address
Shahid Beheshti Faculty of Dentistry, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.SBMU.DRC.REC.1401.017
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K12.30
ICD-10 code description
Oral mucositis
Primary outcomes
1
Description
Degree of mucositis
Timepoint
Weekly from the first day of radiotherapy to 2 weeks after radiotherapy
Method of measurement
According to the clinical criteria of the World Health Organization
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: alpha lipoic acid capsules 300 mg twice a day, 2 capsules each time during radiotherapy sessions to be consumed by the patients for two weeks afterwards. Alphalipoic acid (Raha Pharmaceutical Company): is one of the vitamin-like chemical substances that has an antioxidant function, in the sense that it destroys the toxic radicals created in the body.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ُُShohadaye tajrish hospital
Full name of responsible person
Maryam jarahzade
Street address
Shahrdari St, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
lib.shmc@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gholamreza Farid brothers
Street address
Safeh Industrial Town, km 7 of Shiraz Road, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8179135148
Phone
+98 31 3654 0659
Fax
+98 31 3654 0959
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam jarahzade
Position
Oral medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Faculty of Dentistry, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
maryam.jarahzade92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza khalighi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Faculty of Dentistry, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2302
Fax
Email
Dr.hrkh92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Jarahzade
Position
Oral medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Faculty of Dentistry, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2242 1811
Email
maryam.jarahzade987@gmail.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
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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
Not applicable
When the data will become available and for how long
As soon as the thesis is defended and the article is published, the data will be accessed.
To whom data/document is available
If the article is open access, people can access it by referring to the desired sites.
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Author and researcher of this project Maryam Jarahzadeh with email address maryam.jarahzade92@gmail.com
What processes are involved for a request to access data/document