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IRCT20200408046990N14 IRCT 2023-10-06 Mashhad University of Medical Sciences Investigating the effect of chamomile oral solution on neurological complications caused by chemotherapy regimens containing paclitaxel in cancer patients. Evaluation of the protective effect of chamomile oral solution on the incidence of neurotoxicity caused by chemotherapy regimens containing paclitaxel in cancer patients 2023-10-23 anticipated 40 Complete https://irct.ir/trial/72529 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Various cancers treated by paclitaxel. Intervention 1: Intervention group: In the drug group, starting one day before the paclitaxel injection, three times a day each time in the amount of 5 cc of the oral solution containing the hydroalcoholic extract of chamomile (each 5 cc contains 500 mg of dry extract) every two or three weeks for 4 courses for It will be a maximum of 12 weeks. Intervention 2: Control group: In the placebo group, a placebo is consumed three times a day, 5 cc each time. The dosage of paclitaxel will be 175 mg/m2 every two or three weeks for 4 courses for a maximum of 12 weeks. Yes - There is a plan to make this available What will be shared: The findings will be published in an article. Study protocol and statistical analysis will be used for article publication. When: One year after the end of the study it will be published and available in databases. To whom: If the funding sponsor allowed, the findings will be available for researchers, clinicians, and scientific centers. Conditions: The other researchers can use our findings in their review articles and meta analysis. Where to obtain: 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 How to obtain: 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 Comments:
public Sepideh Elyasi
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
Faculty of Pharmacy; Ferdowsi University; VakilAbad Boulevard
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Suffering from cancer and starting chemotherapy regimen containing paclitaxel at a dose of 175 mg/m2. age between 18-70 yers 18 years 70 years Both 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, the patient will be excluded from the study. Renal failure (GFR<30 ml/min) Neuropathy at baseline Having diabetes or other disorders that cause neuropathy Taking supplements containing antioxidant compounds Use of neuromodulator drugs such as compounds containing calcium or magnesium and anticonvulsant drugs such as gabapentin and antidepressants from tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors. Taking warfarin alcohol consumption Smoking Lack of patient satisfaction Having a history of allergy to chamomile BMI>30 Use of other neurotoxic drugs in the chemotherapy regimen, such as platinums or vincristine Suffering from concurrent neuromuscular diseases such as myasthenia gravis Guillain Barre syndrome, multifocal motor neuropathy and chronic inflammatory demyelinating polyneuropathy C00-C97 malignant neoplasms Treatment - Drugs Placebo Intervention group: In the drug group, starting one day before the paclitaxel injection, three times a day each time in the amount of 5 cc of the oral solution containing the hydroalcoholic extract of chamomile (each 5 cc contains 500 mg of dry extract) every two or three weeks for 4 courses for It will be a maximum of 12 weeks. Control group: In the placebo group, a placebo is consumed three times a day, 5 cc each time. The dosage of paclitaxel will be 175 mg/m2 every two or three weeks for 4 courses for a maximum of 12 weeks. Neuropathy. Timepoint: at baseline-after each course-at the end of study. Method of measurement: based on NCI-CTC (national cancer institute-common toxicity criteria version 5). Sleep assessment. Timepoint: at the beginning of study-at the end of study. Method of measurement: Based on the Pittsburgh Sleep Quality Index. Assessment of anxiety. Timepoint: at the beginning of study-at the end of study. Method of measurement: Generalized Anxiety Disorder scale questionnaire index. Mashhad University of Medical Sciences Approved 2023-08-28 Ethics committee of Mashhad University of Medical Sciences Qureshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)