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IRCT20200331046902N1 IRCT 2023-02-07 Khoram-Abad University of Medical Sciences Investigation the effect of oral Rosemary extract on chemotherapy induced peripheral neuropathy Investigation the effect of oral Rosemary hydro-alchohlic extract on chemotherapy induced peripheral neuropathy in the patients with metastatic gastrointestinal malignancy: A randomized clinical trial 2023-02-05 anticipated 52 Complete https://irct.ir/trial/46956 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method in this study is a non-probability sequential method based on including and excluding criteria and until the completion of the sample volume. Allocation of samples in study groups is done by random block method. Random allocation: in order to equalize the distribution of the important confounders of gender, age and type of cancer, classes based on these variables are as follows: male class/female class, age less than 60 years/over 60 years and cancer of the esophagus, cardia, stomach, pancreas, gall bladder , small intestine, large intestine, sigmoid, rectal and anal are created and then they are placed in 2 study groups in a balanced way by block randomization, Blinding description: In this study, after meeting the including criteria's and completing the informed consent form, the patients will be randomly assigned to one of two groups A or B, and based on this grouping, the patient will be given either A or B can. Can A contains 500 mg capsules of medicine (rosemary extract) and can B contains 500 mg placebo capsules (starch). Only the main researcher is aware of the contents of cans A and B, and the nurses taking the sample and assessing the outcomes, the patients, the medical staffs and the person analyzing the data are not aware of the contents of cans A and B. In case of serious complications and questions of the attending physician, the contents of the cans will be explained to them. It is explained to the patient that he may randomly receive placebo or rosemary extract, in both cases the patient will not be deprived of his usual treatments. 2-3 chemotherapy induced peripheral neuropathy. Intervention 1: Intervention group: In this group, patients are given cans containing 500 mg capsules and the patient is asked to take one oral capsule containing 500 mg of dried rosemary extract every 8 hours for two months from the second session of chemotherapy. Rosemary plant extract was prepared by the standard method at Razi Medicinal Plants Research Center in Khorramabad. Intervention 2: Control group: In this group (placebo), the patient is asked to take a can containing 500 mg capsules three times a day for two months. 500 mg capsules in this group contain 500 mg of starch as a placebo. In both the intervention and placebo groups, the patient will not be deprived of any conventional treatment. Yes - There is a plan to make this available What will be shared: All the data of this research will be shared after de-identifying people. When: The start of the data access period will be 6 months after the results of the data are published. To whom: The data of this project will be made available to all researchers and even people working in the industry upon official request. Conditions: If the rights of the main researchers and project implementers are respected, the data of this project can be used. Where to obtain: By e-mail to the correspondent author of the article or project manager at the following addresses: Email: shahrama20@gmail.com Mobile phone: 0098 9168608836 How to obtain: The applicant must first email his written request specifying the purpose of using the data to the project manager, then the agreement on how to use the information and respect the rights of the main project managers must be signed by the parties. After signing the contract, the data will be available to the requester in less than a month. Comments:
public Shahram Ahmadi Somaghian
No. 66, Shahid Daraei Alley, Enghelab Ave, Khorramabad
Khorramabad Iran (Islamic Republic of) 6816938154 +98 66 3322 2156 shahrama20@gmail.com Khoram-Abad University of Medical Sciences scientific Yahya Baharvand Iran Nia
The end of Honar-e-Haftom, Faze Yek, Khorramabad
Khorramabad Iran (Islamic Republic of) 6817748787 +98 66 3333 6145 shahrama20@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Patients with metastatic gastrointestinal cancers aged 25 to 80 years undergoing chemotherapy with oxaliplatin-containing chemotherapy regimens. 25 years 80 years Both Patients who have previously received a chemotherapy regimen containing neurotoxic drugs and now have peripheral neuropathy. Patients receiving other neurotoxic drugs (such as some HIV drugs) at the same time as chemotherapy. Patients with a history of diabetes mellitus and peripheral neuropathy caused by nerve compression (such as carpal tunnel or tarsal syndrome, radiculopathy, spinal stenosis, brachial plexopathy) Patients who, at the same time as chemotherapy, start taking drugs that reduce neuropathy symptoms (such as SNRI drugs) and pain relievers such as acetaminophen, pregabalin, and NSIDs, or change their amount during treatment. Patients with psychological disorders such as: severe depression, patients with suicidal thoughts, bipolar diseases Patients who consume alcohol. Patients with significant impairment of liver and kidney tests Patients who do not agree to consume rosemary extract or do not agree to participate in the study in any way. The patient is unable to tolerate rosemary extract during the study. Prevention Placebo Intervention group: In this group, patients are given cans containing 500 mg capsules and the patient is asked to take one oral capsule containing 500 mg of dried rosemary extract every 8 hours for two months from the second session of chemotherapy. Rosemary plant extract was prepared by the standard method at Razi Medicinal Plants Research Center in Khorramabad. Control group: In this group (placebo), the patient is asked to take a can containing 500 mg capsules three times a day for two months. 500 mg capsules in this group contain 500 mg of starch as a placebo. In both the intervention and placebo groups, the patient will not be deprived of any conventional treatment. Chemotherapy induced peripheral neuropathy. Timepoint: At the beginning of the study, and then before the start of each chemotherapy session for up to two months. Method of measurement: Based on the EORTC-CIPN20 questionnaire and measuring symptoms by a research expert based on the Total Neuropathy Score (TNS) scale. Severity of neuropathic pain based on Numerical Rating Scale tool. Timepoint: At the beginning of the study, and then before the start of each chemotherapy session for up to two months. Method of measurement: Measurement of symptoms by an investigator based on the Numerical Rating Scale tool. Quality of life score. Timepoint: At the beginning of the study, and then before the start of each chemotherapy session for up to two months. Method of measurement: Based on the EORTC QLQ-C30 questionnaire. Khoram-Abad University of Medical Sciences Approved 2021-04-20 Ethic committee of Lorestan University of Medical Sciences Shahid Rahimi hospital, Azadi square, Khorramabad Khorramabad Lorestan Iran (Islamic Republic of)