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IRCT20180722040556N10 IRCT 2024-01-28 Esfahan University of Medical Sciences Curcumin effects on the prevention of peripheral neuropathy-induced by chemotherapy regimen containing paclitaxel in breast cancer patients; a randomized, double blinded and placebo-controlled clinical trial Curcumin effects on the prevention of peripheral neuropathy-induced by chemotherapy regimen containing paclitaxel in breast cancer patients; a randomized, double blinded and placebo-controlled clinical trial 2024-04-03 anticipated 60 Complete https://irct.ir/trial/70605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: This study is a clinical trial that is controlled with placebo and double-blind. The collection of samples is expected to take 1 year and This collection will be done on patients in the hematology-oncology center of Seyed al-Shohada Hospital or affiliated clinics of this hospital. Seyyed al-Shohada Hospital is a specialized 200-bed hospital and a reference in the field of treating patients with blood cancers or solid tumors and related problems located in Isfahan city. It is also well equipped in terms of medical staff and necessary facilities to treat such patients, Randomization description: The randomization of the samples will be based on Blocked randomization method. Information such as the number of treatment groups (two main intervention groups for example A and placebo for example B), The size of the blocks (a multiple of the number of groups that will be chosen in this study to reduce the complexity of the work, size 4) and the total number of patients (sample size of 33 people) to the internet software machines specific for this calculation (for example, available at https://www. .sealedenvelope.com/simple-randomiser/v1/lists) will be imported and According to the codes obtained by the final analysis, a code will be assigned to each patient who enters the study, which will determine the type of group that should take medicine or placebo. Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. In this method, equal blocking will be used. In this way, the samples are randomized in two groups as much as possible. After the end of sampling, the code of each patient is opened and matched with the output of the software, and it is tried as much as possible so that the person who collects the information and the interventionist knows about the code information of the drugs after analyzing the data, Blinding description: Nanocurcumin capsule (40mg) and placebo will be provided by "Exir Nano Sina" company. Each nanocurcumin capsule contains (72% curcumin, 25% demethoxycurcumin, 3% bismethoxycurcumin). Each placebo capsule contains (polysorbate 80). The placebo and the original drug will be identical in all respects. Both are prepared from the same factory so that the drug and the placebo are placed in the same package, thus the blinding method can be done well. Then placebo and supplement products with a specified number for a patient (Assuming to complete the entire duration of the course with a dose three times a day) will be provided to the student with a special code. The information of this specific code on the drug packages is only available to the main project manager, who is not involved in sampling, and other colleagues (patients, students, doctors who perform clinical evaluation) do not know about these codes.Therefore, sampling will be done with a blind method. 3 Breast cancer patients. Intervention 1: In the intervention group, patients received 40 mg nanocurcumin capsules three times a day for 2 months. Intervention 2: in placebo group, patients use nanocurcumin drug placebo three times a day. Yes - There is a plan to make this available What will be shared: All collected data When: From the july of 2024 To whom: All academic centers Conditions: All documents with citation Where to obtain: E-mail address How to obtain: After sending a request, we will call the related person and the data will be revealed in less than one week. Comments:
public Azadeh moghaddas
Faculty of Pharmacy,Isfahan University Of Medical Sciences,Hezar Jarib street.Isfahan.Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 7074 moghaddas@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Azadeh moghaddas
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 7074 moghaddas@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All adult women (18 years and older and less than 65 years old) with non-metastatic breast cancer who received paclitaxel at a dose of 175 mg/m2 every 3 weeks for 4 courses after completing an anthracycline-containing regimen for the first time in the treatment process (New case patients). The patient must have compliance in taking medication for at least 8 weeks and have enough ability to swallow and consume nanocurcumin capsules orally. Patients should have the necessary literacy to fill in the questionnairesand also have the necessary cooperation in performing neurological tests. Patients who do not have any history of liver and kidney failure. 18 years 65 years Female Patients with a history of any peripheral neuropathy Patients with a history of coronary artery disease and peripheral vascular disease All diabetic patients Pregnancy and breastfeeding taking anticonvulsant drugs, Tricyclic antidepressants, other neuropathic pain relievers such as duloxetine Chronic use of cigarettes, drugs or alcohol Patients with a history of peripheral neuropathy (eg, hereditary, with nutritional factors and paraneoplastic causes) Those who have received chemotherapy for another malignancy in the past. Metastasis to the central nervous system or any neurological involvement due to metastasis or tumor pressure Users of anti-platelet drugs such as aspirin, etc. and oral and injectable anti-thrombosis Malignant (C50-C50) Prevention Prevention In the intervention group, patients received 40 mg nanocurcumin capsules three times a day for 2 months. in placebo group, patients use nanocurcumin drug placebo three times a day Determining and comparing the severity of neuropathy before and after the intervention in each of the intervention and placebo groups. Timepoint: Before the start of chemotherapy - before the second cycle of chemotherapy - before the third cycle of chemotherapy. Method of measurement: Determining and comparing the mean score of NSS, NDS and MNSI index, and comparing neurological tests before and after the intervention. Esfahan University of Medical Sciences Approved 2023-04-25 Ethics committee of isfahan university of medical sciences Isfahan University of medical Scienices, hezar jarib street, Isfahan, Iran isfahan Isfehan Iran (Islamic Republic of)