Study the radioprotective effects of oral atorvastatin on side effects and effectiveness of radiotherapy in patients with breast cancer: A randomized clinical trial, evaluate of oxidative stress biomarkers and quality of life
Determination of the Effect of Oral Atorvastatin on the Complications and Effect of Radiation Therapy in Patients with Breast Cancer
Design
A simple randomized clinical trial with a placebo-controlled, double-blind, control group with a sample size of 90
Settings and conduct
The researcher identifies eligible patients in the radiotherapy department of Imam Khomeini hospital in sari. First, patients will receive written consent to enter the research.They will then be selected as a research sample.
Professor of supervisor, drugs will divide the numbers into two groups using a random number table.
1- An intervention group containing 40 mg per day of atorvastatin and
2. Control group containing placebo
So the researchers and patients will be blind in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women with breast cancer
Based on bra / breast size ≤85
Not having sensitivity to atorvastatin
exclusion criteria:
Taking anti-inflammatory drugs
Taking antidepressants drugs
cardiovascular patients
history of systemic lupus and scleroderma.
Intervention groups
Both intervention and control groups will receive radiotherapy with a standard two-way tangent technique
5000CG / 25F photon.
The intervention group will receive 40 mg atorvastatin and the control group will receive the placebo.
Main outcome variables
Evaluation of skin dermatitis and assessment of the quality of life of patients with breast cancer undergoing radiotherapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181005041239N1
Registration date:2019-02-01, 1397/11/12
Registration timing:prospective
Last update:2019-02-01, 1397/11/12
Update count:0
Registration date
2019-02-01, 1397/11/12
Registrant information
Name
Mahmonir Danesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7343
Email address
m.danesh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the radioprotective effects of oral atorvastatin on side effects and effectiveness of radiotherapy in patients with breast cancer: A randomized clinical trial, evaluate of oxidative stress biomarkers and quality of life
Public title
The effect of radiation protection of oral atorvastatin in patients with breast cancer receiving radiotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have the ability to read and write in farsi or be able to communicate if they are illiterate.
Women aged 18 and over
Women with breast cancer who receive radiation dosage during treatment with the standard technique of bilateral tangent 5000CG / 25F Photon.
Awareness of the person, time and place
The possibility of making direct telephone calls to a patient or an active member of his family (to follow the samples)
Based on bra / breast size ≤85
Women without known diseases and under medical treatmentSuch as diabetes, thyroid disorders, known liver disease, immune system weakness, rhabdomyolysis and cardiovascular disease, hyperlipidemia, depression and anxiety and taking statins with a doctor's order.
Not using a psychologist or psychiatrist's counsel at the time of the study or at least a month before the study begins.
Exclusion criteria:
Allergy to atorvastatin
Taking anti-inflammatory drugs
Addicted to alcohol, cigarettes and drugs
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to study.
The presenter will place the envelopes containing the medication or placebo on the order of one to ninety by using random numbers. For each research sample, a research folder with the same code number or placebo code that contains all the tools for patient information will be formed.
The drug envelope or placebo will be given to the research samples on the first day of the research entry. The date of the start of medication use will be noted on the envelope of medicines by label. The researcher will also remind them of the timely use of the drug by contacting the patient's telephone number. Taking a medication or placebo two weeks before the date of the first radiotherapy session will be one night.
Blinding (investigator's opinion)
Double blinded
Blinding description
The supervisor will place the envelopes containing the medication or placebo on the order of 1 to 90 with random numbers.
In this way, the researcher, the subjects, and the doctors and statisticians will be blind to the intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem Ave, Moalem Squer
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.MAZUMS.REC.1397.150
Health conditions studied
1
Description of health condition studied
Breast cancer & Radiotherapy
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Evaluation of skin inflammation
Timepoint
Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done.
Method of measurement
radiation therapy oncology group (RTOG)
2
Description
Evaluation of the degree of itching,
Timepoint
Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done.
Method of measurement
visual scale analog
3
Description
Assessing the amount of pain
Timepoint
Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done.
Method of measurement
visual scale analog
4
Description
Evaluation of C reactive proteains
Timepoint
The CRP marker is measured once before the intervention and once after the completion of radiotherapy
Method of measurement
This marker is quantitatively quantified by assessing the blood serum of patients.
5
Description
Evaluation of oxidative stress in blood
Timepoint
Once in the first intervention and once after the completion of radiotherapy, the patient's serum is measured.
Method of measurement
This marker is quantitatively quantified by assessing the blood serum of patients.
6
Description
Evaluation of burning rate
Timepoint
Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done.
Method of measurement
visual scale analog
7
Description
Evaluate the amount of edema
Timepoint
Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done.
Method of measurement
Self-declaration of patients and clinical examination
Secondary outcomes
1
Description
quality of life
Timepoint
Before intervention radiotherapy and after the completion of radiotherapy
Method of measurement
1. A questionnaire for quality of life for cancer patients EORTC QLQ – BR23 . 2. The quality of life of cancer patients belonging to the European Cancer Research Organization and the specific breast cancer questionnaire EORTC QLQ C-30.
Intervention groups
1
Description
The intervention group: Women with breast cancer will receive radiotherapy with the standard technique of two-sided 5000CG / 25F photon tangent in the radiation center at Imam Khomeini hospital in sari. Patients are receiving the film coated tablet atorvastatin 40 mg without line per daily. Tablets manufactured by sobhan darou Pharmaceutical Company. Beginning of tablet ingestion is two weeks before radiotherapy and with the completion of radiotherapy, the tablets are consumed.
Category
Treatment - Drugs
2
Description
Control group: Women with breast cancer will receive radiotherapy with the standard technique of two-sided 5000CG / 25F photon tangent in the radiation center at Imam Khomeini hospital in sari. Patients will receive one placebo per night. Beginning of placebo ingestion is two weeks before radiotherapy and with the completion of radiotherapy, the tablets are consumed. The placebo has been produced at sari school of pharmacy under the supervision of the supervisor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Mahmonir Danesh
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
33131-48166
Phone
+98 11 3336 1700
Fax
Email
emamhospital@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Moalem Square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
m.saeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Jalal Hosseinimehr
Position
Ph.D Professor Department of Radiopharmacy Faculty of Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Radiobiology and Radio safety
Street address
Sea Road, Supreme Prophet's Complex, Faculty of Pharmacy
City
Sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 4308
Email
sjhosseinim@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Jalal Hosseinimehr
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiobiology and Radio safety
Street address
Sea Road, Supreme Prophet's Complex, Faculty of Pharmacy
City
sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 4308
Email
sjhosseinim@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahmonir Danesh
Position
Resident
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
18 km of Khazarabad road, 18 km of Khazarabad road Complex of Payabar Azam, University of Medical Sciences, Faculty of Pharmacy
City
Sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 4308
Fax
+98 11 3354 4308
Email
mahmonir.danesh.ir@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
"No more information".
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available