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

The effect of nanocurcumin in reducing the side effects of chemotherapy with taxane drugs, especially neuropathy in patients with breast cancer.

In the intervention group, patients received 40 mg nanocurcumin capsules three times a day for 2 months. Also, in the parallel placebo group, patients use nanocurcumin drug placebo three times a day

Clinical trial - Isfahan University of Medical Sciences

Inclusion criteria - All adult women (18 years and older and less than 65 years old) with non-metastatic breast cancer - Patients who do not have any history of liver and kidney failure Exclusion criteria - 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 - 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. - Users of anti-platelet drugs such as aspirin, etc. and oral and injectable anti-thrombosis

In the intervention group, patients received 40 mg nanocurcumin capsules three times a day for 2 months. Also, in the parallel placebo group, patients use nanocurcumin drug placebo three times a day

Prevention of peripheral neuropathy caused by paclitaxel-containing regimen

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.

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.

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From the july of 2024

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