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IRCT20220115053723N1 IRCT 2023-01-01 Tehran University of Medical Sciences effects of duloxetine and venlafaxine on the taxol-induced neuropathy comparison study of the effects of duloxetine and venlafaxine on neuropathy in breast cancer patients with taxol-induced acute peripheral neuropathy 2019-02-20 anticipated 80 Complete https://irct.ir/trial/62540 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the random allocation rule of the restricted randomization method has been used. The random allocation represents a large block for the entire sample size, and the number of individuals assigned to each group will be balanced at the end of the study. In this method, they selected the initial set of total sample sizes and then randomly interpreted them into different groups. In this study, patients were randomly divided into the two groups. Sortition was used to construct the sequence and the results were recorded. 2 neuropathy. Intervention 1: Intervention group: duloxetine - Patients who met the criteria for entering the study were entered into the study after randomization, and these patients were entered after neurological examination and confirmation of neuropathy caused by taxanes with history and examination and questionnaire scores. In the duloxetine group, they were treated with 30 mg daily from the beginning. In case of tolerance and no side effects at the end of the first week, the drug dose reached 60 mg. At the end of the 10th week, the patients were examined by HADS, McGill and DN4 questionnaires, and QLQ questionnaire was also used to check the quality of life. In case of drug side effects and drug intolerance, the patient was excluded from the study. Intervention 2: Intervention group: venlafaxine - Patients who met the criteria for entering the study were entered into the study after randomization, and these patients were entered after neurological examination and confirmation of neuropathy caused by taxanes with history and examination and questionnaire scores. In the venlafaxine group, they were treated with 37.5 mg daily from the beginning. In case of tolerance and no side effects at the end of the first week, the drug dose reached 75mg. At the end of the 10th week, the patients were examined by HADS, McGill and DN4 questionnaires, and QLQ questionnaire was also used to check the quality of life. In case of drug side effects and drug intolerance, the patient was excluded from the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The data release schedule has not yet been determined
public Hanieh Radkhah
No. 23, Akbarian Azar st. Sattarkhan st.
Tehran Iran (Islamic Republic of) 1441654345 +98 21 6691 6328 Hanieh.Radkhah@gmail.com Tehran University of Medical Sciences scientific Hanieh Radkhah
No. 23, Akbarian Azar st. Sattarkhan st.
Tehran Iran (Islamic Republic of) 1441654345 +98 21 6691 6328 Hanieh.Radkhah@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) patients with breast cancer who treated with taxol (paclitaxel) for chemotherapy with peripheral neuropathic and neuropathic pain with confirmation of physical examination pain score 3 or more according to MacGill questionnaire No metastasis life expectancy more than 3 months Hospital anxiety and depression scale score less than 20 according to HADS questionnaire Neuropathic score more than 3 in DN4 questionnaire. 18 years no limit Female metastatic breast cancer pregnancy and breast feeding HADS score more than 20 using antidepressant and anti epileptic drugs and opioids paralytic neuropathic syndromes G64 Other disorders of peripheral nervous system Treatment - Drugs Treatment - Drugs Intervention group: duloxetine - Patients who met the criteria for entering the study were entered into the study after randomization, and these patients were entered after neurological examination and confirmation of neuropathy caused by taxanes with history and examination and questionnaire scores. In the duloxetine group, they were treated with 30 mg daily from the beginning. In case of tolerance and no side effects at the end of the first week, the drug dose reached 60 mg. At the end of the 10th week, the patients were examined by HADS, McGill and DN4 questionnaires, and QLQ questionnaire was also used to check the quality of life. In case of drug side effects and drug intolerance, the patient was excluded from the study. Intervention group: venlafaxine - Patients who met the criteria for entering the study were entered into the study after randomization, and these patients were entered after neurological examination and confirmation of neuropathy caused by taxanes with history and examination and questionnaire scores. In the venlafaxine group, they were treated with 37.5 mg daily from the beginning. In case of tolerance and no side effects at the end of the first week, the drug dose reached 75mg. At the end of the 10th week, the patients were examined by HADS, McGill and DN4 questionnaires, and QLQ questionnaire was also used to check the quality of life. In case of drug side effects and drug intolerance, the patient was excluded from the study. Pain score 3 or more according to MacGill questionnaire. Timepoint: At the beginning of the study and 10 weeks after starting the drug. Method of measurement: MacGill questionnaire. Hospital anxiety and depression scale score less than 20 according to HADS questionnaire. Timepoint: At the beginning of the study and 10 weeks after starting the drug. Method of measurement: HADS questionnaire. Neuropathic score more than 3 in DN4 questionnaire. Timepoint: At the beginning of the study and 10 weeks after starting the drug. Method of measurement: DN4 questionnaire. Tehran University of Medical Sciences Approved 2019-01-30 Ethics committee of Imam Khomeini Hospital -Tehran University of Medical Sciences No. 23, Akbarian Azar st., Sattarkhan St., Tehran Tehran Tehran Iran (Islamic Republic of)