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IRCT20201128049515N2 IRCT 2021-04-22 Mazandaran University of Medical Sciences Evaluation the efficacy of extract of Dracocephalum in chemotherapy Evaluation the efficacy of hydroalcoholic extract of Melissa officinalis L. (Dracocephalum) in chemotherapy‐induced peripheral neuropathy: A double‐blinded randomized placebo‐controlled clinical trial 2021-05-21 anticipated 74 Complete https://irct.ir/trial/55717 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the study, stratified block randomization will be applied. Patients will be divided into four groups according the medication that they are receiving: 1) Platinum drugs (cisplatin or oxaliplatin) 2) Vincristine 3) Bortezomib 4) Taxans. Then, in every category, patients will be allocated into two groups of intervention and control based on random sequence created in a quadruple manner (online randomization). Four randomized sequences of each group will be used separately by online random system. Dracocephalum and the placebo will be placed in packets based on previously defined codes and will be handed to participants based on defined randomized system, Blinding description: Patients grouping and the type of intervention will be known only to the primary investigator, and others (patients, fellowship colleague who will be the responsible of clinical assessments of patients, data collecting staff, the statistic analyzer and article draft writers) will not be aware of patients grouping. 3 Chemotherapy induced peripheral neuropathy. Intervention 1: Intervention group: beside the 300 mg daily dose of gabapentin will receive hydroalcoholic extract of Melissa officinalis L plant in capsule form (1 capsule containing 300 mg of the drug, 2 times a day) after each main meal, for 3 months. The plant will be provided by the medicinal herb production farm in Behshahr. Intervention 2: Control group: will receive 300 mg daily dose of gabapentin and 300 mg placebo every 12 hours for 3 month. Placebo is similar to the intervention drug in appearance, color and taste. Yes - There is a plan to make this available What will be shared: All data will be informed to public after the deletion of participants name. When: After the end of the study. To whom: Data will be provided for researchers and industries. Conditions: Other analysis is not authorized on data. Where to obtain: Send your request to Dr. Ramin Shekarriz email (r.shekarriz@mazums.ac.ir) to receive datdocuments and data. How to obtain: The request will be sent to vice chancellor for research and technology of Mazandaran University of Medical Sciences after sending to r.shekarriz@mazums.ac.ir email address and then will be assessed by the vice chancellor and the result will be informed. Comments:
public Dr. Ramin Shekarriz
Cancer Lab, 3rd floor, Cancer comprehensive center, Imam Khomeini hospital, Amir Mazandarani Blvd, Sari Town
Sari Iran (Islamic Republic of) 48166234356 +98 11 3336 4044 r.shekarriz@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Ramin Shekarriz
Cancer Lab, 3rd floor, Cancer comprehensive center, Imam Khomeini hospital, Amir Mazandarani Blvd, Sari Town
Sari Iran (Islamic Republic of) 48166234356 +98 11 3336 4044 r.shekarriz@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with cancer between 18 to 75 years old Patients who has received their first neurotoxic chemotherapy by using Vinca alkaloids, platinum and taxane derivatives. Patients with neuropathy symptoms. 18 years 75 years Both Other possible reasons for neuropathy (diabetes, thyroid function disorder, B12 deficiency, alcohol abuse) Taking other medications for neuropathy symptoms simultaneously Taking any type of anti oxidant supplements in recent two months Pregnant or nursing women G13.0 Paraneoplastic neuromyopathy and neuropathy Treatment - Drugs Placebo Intervention group: beside the 300 mg daily dose of gabapentin will receive hydroalcoholic extract of Melissa officinalis L plant in capsule form (1 capsule containing 300 mg of the drug, 2 times a day) after each main meal, for 3 months. The plant will be provided by the medicinal herb production farm in Behshahr. Control group: will receive 300 mg daily dose of gabapentin and 300 mg placebo every 12 hours for 3 month. Placebo is similar to the intervention drug in appearance, color and taste. Chemotherapy induced peripheral neuropathy. Timepoint: At initial assessment and 1,2 and 3 month after initial assessment. Method of measurement: Performance status- Eastern Cooperative Oncology Group questionnaire (PS-ECOG). The efficacy of treatment. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Evaluation of neuropathy symptom alleviation and questionnaire. Pain intensity. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Based on visual analogue scale and questionnaire. Adverse effects. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Common Terminology Criteria for Adverse Events and questionnaire. Quality of life. Timepoint: At initial assessment of patient and 1, 2, and 3 month after the initial assessment. Method of measurement: Questionnaire developed to assess the quality of life of cancer patients. Mazandaran University of Medical Sciences Approved 2021-01-27 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for research and technology, Moalem Sq, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)