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IRCT20151021024645N3 IRCT 2021-11-20 Ahvaz University of Medical Sciences The application of metformin in protecting chemotherapy-induced neuropathy The application of metformin in protecting chemotherapy-induced neuropathy in patients with breast cancer 2021-11-06 anticipated 40 Complete https://irct.ir/trial/59447 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The study subjects are divided into two groups, receiving routine chemotherapy. In the intervention group, metformin is used in addition to routine chemotherapy, at the beginning of the study (before the intervention), at the end of cycle 6, and the end of cycle 12, Randomization description: Randomization method: Block randomization using 2 and 4 blocks (randomly) Randomization unit: Individual Randomization tool: Web application or software Description of allocation concealment: Using opaque sealed envelopes with a random sequence, Blinding description: The laboratory collaborators are not aware of the intervention and control people, and the samples are given to them with a code. The patients are also unaware of the potential benefits of using metformin to protect against neuropathy because they have to complete a questionnaire. 2-3 Breast cancer. Intervention 1: Intervention group: The drug is metformin, prescribed in the form of three tablets of 500 mg per day (1500 mg per day in total) for three months from the first day of chemotherapy. Due to the availability of the medicine, it is prepared from the best available in the market. Intervention 2: Control group: This group only uses the paclitaxel chemotherapy regime for three months. Yes - There is a plan to make this available What will be shared: The results of the questionnaire are published in full. Some laboratory results are published. When: Access is open six months after the article is published. To whom: Given the importance of the study, everyone can have access Conditions: The use of data is only permitted for modeling in a similar study. Where to obtain: The data can be accessed by contacting Daryushpurrahman@gmail.com How to obtain: Mention the purpose of the request and introduce the people who have access to the data. Comments:
public Hossein Karimpourian
Golestan
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3375 0417 Hosseinkarimpourian@gmail.com Ahvaz University of Medical Sciences scientific Hossein Karimpourian
Golestan
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3375 0417 Hosseinkarimpourian@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients affected with breast cancer, based on the biopsy findings, 18 years no limit Female Active diabetic patients or those with a history of diabetes The history of neuropathy or nerve damage Anemia The history of chemotherapeutic agent use Hyperthyroidism or thyrotoxicosis The patient with digestive problems who may less likely tolerate metformin The patients with contraindications for metformin treatment 2C6Z Carcinoma of breast, specialised type Prevention Diagnosis Intervention group: The drug is metformin, prescribed in the form of three tablets of 500 mg per day (1500 mg per day in total) for three months from the first day of chemotherapy. Due to the availability of the medicine, it is prepared from the best available in the market. Control group: This group only uses the paclitaxel chemotherapy regime for three months. Severity of neuropathy. Timepoint: At the beginning of the study and in cycles 2, 4, 6, 8, 10 and 12. Method of measurement: PNQ questionnaire, CTCAE questionnaire. Laboratory parameters. Timepoint: At the beginning of the study (before the intervention), the end of cycle 6 and the end of cycle 12. Method of measurement: Laboratory evaluation. Ahvaz University of Medical Sciences Approved 2021-10-17 Ethics committee of Ahvaz jundishapur University of Medical Sciences Golestan Ahvaz Khouzestan Iran (Islamic Republic of)