Evaluation of the protective effect of chamomile oral solution on the incidence of neurotoxicity caused by chemotherapy regimens containing paclitaxel in cancer patients

Effectiveness of chamomile oral solution in preventing neurotoxicity caused by regimens containing paclitaxel in cancer patients

In this study, there is a three-way blind randomized clinical trial with placebo with parallel groups on 40 cancer patients.

Forty cancer patients in the Omid Hospital, Mashhad who meet the inclusion criteria will be included randomly to the intervention and placebo groups in equal proportions. In the drug group, starting one day before the paclitaxel injection, 5 cc of an oral solution containing chamomile hydroalcoholic extract (each 5 cc contains 500 mg of dry extract) prepared by Kimiagar Tous Pharmaceutical Company three times a day. to be The dosage of paclitaxel will be 175 mg/m2 every two or three weeks for 4 courses for a maximum of 12 weeks.

Inclusion criteria: Suffering from cancer and starting chemotherapy regimen containing paclitaxel at a dose of 175 mg/m2; Age 18-70 years. Exclusion criteria: Liver failure (due to the change in drug clearance): If the ALT and AST tests are more than two to three times the normal level at the beginning of the treatment; Renal failure (GFR<30 ml/min); Taking supplements containing antioxidant compounds.

In the drug group, starting one day before the paclitaxel injection, 5 cc of an oral solution containing chamomile hydroalcoholic extract (each 5 cc contains 500 mg of dry extract) prepared by Kimiagar Tous Pharmaceutical Company three times a day. In the placebo group, starting one day before the paclitaxel injection, 5 cc of placebo solution prepared by KimiagarTous Company three times a day. The dosage of paclitaxel will be 175 mg/m2 every two or three weeks for 4 courses for a maximum of 12 weeks in both groups.

Evaluation of neuropathy occurrence, based on NCI-CTC criteria version 3,

Randomization will be done based on the table of random numbers prepared from randomization.com. In this study, the allocation of people to two groups will be done using the 4 permutation block method. In this method, A represents the person who receives the intervention and B represents the person who is placed in the control group. The letter A or B will be assigned to the drug or placebo by a person not involved in entering the patients, evaluating the patients, and analyzing the data, and will not be decoded until the end of the analysis. Considering the quadruple block; We give code 0 to AABB permutation, code 1 to ABAB permutation, code 2 to ABBA, code 3 to BAAB, code 4 to BBAA and code 5 to BABA.Then, using the table of random numbers, we randomly select a starting point and then consider 5 numbers in a row or column. Considering the order of the numbers in the table, we place the permutation corresponding to each number we come across, for example, if the first three numbers of the table of random numbers are 1, 0, and 5 respectively, the order of receiving treatment by the first 12 people in two groups, respectively From left to right it will be ABABAABBBABA. In this process of generating random numbers, we skip the numbers 6 to 9 to select blocks of four. Randomization type: 1- Simple 2- Blocked block 3- Stratified

In this study, the drug packages prepared in the two intervention and control groups are the same, and the form of the oral formulation of the drug and the placebo are also similar to each other, and both are prepared by the same pharmaceutical company with a similar appearance and are provided to the plan administrators.

The findings will be published in an article. Study protocol and statistical analysis will be used for article publication.

One year after the end of the study it will be published and available in databases.

If the funding sponsor allowed, the findings will be available for researchers, clinicians, and scientific centers.

The other researchers can use our findings in their review articles and meta analysis.

For this purpose, you can contact with Sepideh Elyasi, at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven., Mashhad, Iran. Email: elyasis@mums.ac.ir

After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks