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IRCT20240713062420N1 IRCT 2024-09-26 Sabzevar University of Medical Sciences Impact of garlic oil on chemotherapy-induced peripheral neuropathy Impact of topical garlic oil on chemotherapy-induced peripheral neuropathy 2024-10-22 anticipated 66 Complete https://irct.ir/trial/78922 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the specified inclusion criteria, we will perform sampling, followed by random assignment to control and intervention groups using block randomization(AABB, ABAB, ABBA, BABA, BAAB, BBAA) determined by rolling a die. To align the blocks with the numbers on the die, we assign codes 1 to 6 to each of these quaternary blocks. Code 1 corresponds to the AABB block, code 2 to the ABAB block, code 3 to the ABBA block, code 4 to the BABA block, code 5 to the BBAA block, and code 6 to the BAAB block. Since our research requires a sample size of 66 individuals, we will roll the die 17 times (4 * 17 = 68) to ensure that at least 66 samples are included. When matching the die’s outcome to the code associated with the blocks, the letter ‘A’ designates samples placed in the intervention group, while the letter ‘B’ designates samples placed in the control group, Blinding description: Participants, healthcare personnel and researcher are blinded to the garlic oil and placebo (paraffin). To maintain blinding, both the garlic oil and placebo (paraffin) will be provided in identical, coded packaging. It is important to note that the garlic oil closely resembles the paraffin placebo in terms of consistency, appearance, and even odor, as well as the packaging used. N/A Condition 1: Cancer. Condition 2: Chemotherapy induced peripheral neuropathy (CIPN). Intervention 1: Intervention group: In the intervention group, 1 cc of garlic oil is applied twice daily for 6 weeks to the soles of the feet and the backs of the hands and feet, from the wrists to the fingertips. The garlic oil is sourced from Toba Tala Sabz Pharmaceutical Company. Intervention 2: Control group: In the intervention group, 1 cc of garlic oil is applied twice daily for 6 weeks to the soles of the feet and the backs of the hands and feet, from the wrists to the fingertips. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Shamim Shahrestani
No 6, Besat St, Motaharri St
Sabzevar Iran (Islamic Republic of) 9618637548 +98 51 4464 1144 shahrestani.s14@medsab.ac.ir Sabzevar University of Medical Sciences scientific Fereshteh Ghorat
Sabzevar University of medical sciences, TohidShahr Blvd
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 8363 drghorat@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Cancer patients with neuropathy, following chemotherapy, approved by the oncologist, and a pain score greater than 1 based on the McGill Pain Questionnaire-2 (SF-MPQ-2). The use of one of the following chemotherapy regimens that cause neuropathy, including taxane group drugs in weekly, 2-week, or 3-week regimens, such as the AC-Taxol, TCH, TC, or TAC regimens. no limit no limit Both Diagnosis of depression, peripheral vascular disease Use of other drugs effective in treating neuropathy, such as gabapentin, pregabalin, or duloxetine diabetes or alcohol abuse Pregnancy or breastfeeding Severe underlying condition Allergy to garlic oil or a placebo C80.1 G62.0 Malignant (primary) neoplasm, unspecified Drug-induced polyneuropathy Treatment - Drugs Placebo Intervention group: In the intervention group, 1 cc of garlic oil is applied twice daily for 6 weeks to the soles of the feet and the backs of the hands and feet, from the wrists to the fingertips. The garlic oil is sourced from Toba Tala Sabz Pharmaceutical Company. Control group: In the intervention group, 1 cc of garlic oil is applied twice daily for 6 weeks to the soles of the feet and the backs of the hands and feet, from the wrists to the fingertips. Pain intensity. Timepoint: At baseline, at the end of each week and at the end of the sixth week. Method of measurement: Brief Pain Inventory - Short form (BPI-SF) questionnaire. Functional performance. Timepoint: At baseline, at the end of each week and at the end of the sixth week. Method of measurement: Brief Pain Inventory - Short form (BPI-SF) questionnaire. Neuropathy severity. Timepoint: At baseline, at the end of each week and at the end of the sixth week. Method of measurement: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire—Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) questionnaire. Sabzevar University of Medical Sciences Approved 2024-05-07 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohidshahr Blvd Sabzevar Razavi Khorasan Iran (Islamic Republic of)