Effect of Atorvastatin Usage on Oxidative stress-related Marker Superoxide dismutase and Angiogenesis Factors in the Saliva of Patients with Oral squamous cell carcinoma: A Randomized Clinical Trial

Determining the effect of atorvastatin on oxidative stress marker superoxide dismutase, and angiogenesis factors in the saliva of patients with a history of oral squamous cell cancer

A Phase III clinical trial, randomized, triple-blind, active-controlled, on 30 patients.

Patients with oral squamous cell carcinoma at the Hospital are divided into two groups of 15 individuals each after undergoing surgery. Saliva samples are collected from each group using the spitting method, and the levels of oxidative stress marker superoxide dismutase, angiogenesis factors, and Beta-2 microglobulin (B2M) in the saliva are measured in the laboratory using the qRT-PCR method. This process is repeated after 1 month, and the results are compared. The surgeon randomly prescribes the drug, and both the analyst and the sample collector are unaware of which group the samples belong to.

Inclusion criteria: Patients with oral squamous cell carcinoma; Ability to personally provide written informed consent; Biopsy result of the patient indicates squamous cell carcinoma of the oral mucosa; Having similar histopathology grades Exclusion criteria: Patients who were previously taking statins for any reason; Smoker patients; Patients undergoing treatment with anti-HIV drugs; Having a history of other cancers; The consumption of another drug that interacts with atorvastatin; Patients with specific systemic diseases; Patients with a history of intolerance to statins; Patients with acute liver failure; Pregnant and lactating women

1: Surgery and Atorvastatin, 40 mg pill, daily, for 1 month 2: Surgery

Oxidative stress marker superoxide dismutase, B2M factor, and angiogenesis factors in saliva such as vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), and placental growth factor (PIGF)

Reasons for the implemented changes: The method of data analysis was switched from spectrophotometry to qRT-PCR for increased accuracy. The sampling date for the second phase changed from 3 months to 1 month due to interference with chemotherapy and radiotherapy. The number of radiotherapy sessions varied depending on each patient's condition, potentially leading to unreliable effects and results, hence radiotherapy was excluded from both intervention and control groups. Beta-2 microglobulin was added to the analysis to standardize salivary factor levels based on patient conditions post-surgery and after 1 month. The sampling location was changed to Imam Khomeini Hospital due to non-cooperation from surgeons and a limited number of OSCC patients. The expected patient recruitment date was changed to complete the required study samples.

Considering the sample size of 15 patients in each group, in order to randomize the samples, we write the words "Users of Atorvastatin" and "Control" on two pieces of paper and place them in a container. Then, we randomly select one of the two pieces of paper. The word chosen will determine whether the first patient after surgery is allocated to the "Users of Atorvastatin" group or the "Control" group. The second patient will be allocated to the next group (i.e., patients 1, 3, 5, etc., will be in the "Users of Atorvastatin" group, while patients 2, 4, 6, etc., will be in the "Control" group). This process will continue until all 15 samples are completed in each group. Additionally, due to the surgeon's lack of preference and choice regarding which patient receives the medication, the drug will be prescribed entirely randomly. Moreover, neither the patient nor the person collecting the samples will be aware of the group to which the patient belongs. The study will be fully blinded and randomized.

The first group, which consists of the surgeon, operates based on randomization without any bias or specific criteria when selecting patients for drug prescription. The second and third groups, which involve someone performing the experiment and someone conducting the analysis, are both completely blinded and have no information about the patients.

The level of oxidative stress marker superoxide dismutase, and salivary angiogenesis factors such as VEGF, HGF, PLGF, and the dose of atorvastatin (40 mg), and the histopathology grade of oral squamous cell carcinoma of the patient must be moderate to severe, which can be shared after de-identifying people.

from 2024 until 2030

Dr. Arezoo Aghakouchak Zadeh, Khashayar Ghazanfari

Those who do a similar article and intend to refer to the results of our study to complete their data and also intend to use our results accurately in their work. For the analysis, it should be done according to the opinion of the statistical consultant. I do not know the specific conditions of the patient's information.

To Dr.Arezoo Aghakouchak Zadeh (a.aghakouchakzadeh@gmail.com), Khashayar Ghazanfari (khashyr333@gmail.com) in the Faculty of Dentistry of Alborz University of Medical Sciences

After visiting and informing Khashayar Ghazanfari and checking with Dr. Arezoo Aghakochekzadeh, the information in question will be provided to the applicant.