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IRCT20210308050628N2 IRCT 2025-08-29 Hamedan University of Medical Sciences Investigation of the Effect of Coenzyme Q10 on Neuropathy and Quality of Life in Chemotherapy-Treated Breast Cancer Patients Evaluation of the effect of coenzyme Q10 on prevention of peripheral neuropathy induced by Paclitaxel and improving the quality of life in women with non metastatic breast cancer: a randomized, double-blind clinical trial study 2025-08-23 anticipated 210 Complete https://irct.ir/trial/85388 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This study employs block randomization to allocate participants into intervention and control groups. Blocks of four are used, each represented by a small box containing four balls: two marked with the letter "A" (intervention group) and two with the letter "C" (control group). For each patient, the treating physician randomly draws one ball from the box, and the patient is assigned to the corresponding group. After four patients have been enrolled, the next block is used. Participants in the intervention group receive Coenzyme Q10, while those in the control group are administered a placebo. The study is conducted in a double-blind manner, meaning that both patients and outcome assessors are blinded to group allocation. Only the treating physician is aware of the group assignments. Data are collected in a coded format to ensure confidentiality and minimize the risk of bias during data collection and analysis, Blinding description: The study will be conducted in a double-blind manner, where both the patients and the outcome assessors are blinded to group allocation. Only the treating physician will be aware of the group assignments. All data will be collected in a coded format to ensure confidentiality and minimize bias. 3 Chemotherapy induced Neuropathy. Intervention 1: Intervention group: Prescription of coenzyme Q10 for the prevention and treatment of chemotherapy-induced neuropathy. Intervention 2: Control group: Administration of a placebo, identical in appearance and quantity to the active drug, in the intervention group. 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 I have not decided yet
public Kamal Mohammadian
18 Metri Milad, Ostadan Area
Hamadan Iran (Islamic Republic of) 6516857141 +98 81 3822 7612 km_282@yahoo.com Hamedan University of Medical Sciences scientific Kamal Mohammadian
18 metri milad, Ostadan Area
Hamadan Iran (Islamic Republic of) 6516857141 +98 81 3822 7612 km_282@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Adult women aged 18 to 65 years No history of chemotherapy Histological confirmation of breast cancer Non-metastatic status confirmed by paraclinical findings, including CT scan, bone scan, or PET-CT scan ECOG-PS: 0-2 No history of diabetes or other underlying neuropathic conditions 18 years 65 years Female Prior administration of chemotherapeutic agents ECOG-PS: 3-4 Co-administration of Warfarin pregnancy Hypersensitivity to supplements containing Coenzyme Q10 Prevention Prevention Intervention group: Prescription of coenzyme Q10 for the prevention and treatment of chemotherapy-induced neuropathy. Control group: Administration of a placebo, identical in appearance and quantity to the active drug, in the intervention group The incidence and severity of neuropathy,. Timepoint: Before and One week after completion of chemotherapy. Method of measurement: NCI-CTCAE Version 5.0 and Electrodiagnostic tests including nerve conduction velocity, SNAP amplitude، SNAP latency. Quality of Life (QoL). Timepoint: Before treatment, during treatment q3 weeks and after the end of treatment. Method of measurement: EORTC-QLQ-CIPN20 questionnaire. Hamedan University of Medical Sciences Approved 2025-07-28 Hamadan University of Medical Sciences Shahid Fahmideh Blvd Hamadan Hamadan Iran (Islamic Republic of)