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The effect of radiation protection of oral atorvastatin in patients with breast cancer receiving radiotherapy

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181005041239N1
Enrollment
100
Registered
2019-02-01
Start date
2019-02-04
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer & Radiotherapy. Malignant neoplasm of breast

Interventions

Intervention 1: 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 Khomein

Sponsors

Sari University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion 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

Exclusion criteria: Allergy to atorvastatin Taking anti-inflammatory drugs Addicted to alcohol, cigarettes and drugs

Design outcomes

Primary

MeasureTime frame
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).;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.;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.;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.;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.;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.;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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Jalal Hosseinimehr

Sari University of Medical Sciences

sjhosseinim@mazums.ac.ir+98 11 3354 4308

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026