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

Evaluation of the protective effect of Coenzyme Q10 in Preventing Paclitaxel-induced Peripheral neuropathy and Improving Quality of Life in Patients with Non-Metastatic Breast Cancer

A Phase III double-blind, parallel-group randomized controlled trial will conducted on 210 patients, equally assigned to an intervention group receiving Coenzyme Q10 and a control group receiving placebo (105 patients per group), using block randomization with blocks of four.

This double-blind study, conducted in Hamadan during 2025–2026, will randomly assign eligible patients to receive either Coenzyme Q10 or a placebo. The aim is to assess Coenzyme Q10’s effect on peripheral neuropathy and quality of life. Both patients and outcome assessors will be blinded to group allocation, with only the treating physician informed.

Inclusion criteria: Women aged 18–65 with breast cancer, scheduled for Paclitaxel chemotherapy, ECOG-PS: 0–2, completion of full treatment course and no history of diabetes or neuropathic conditions, Exclusion criteria: prior chemotherapy, warfarin use, pregnancy, severe allergy to Coenzyme Q10, or ECOG status 3–4.

This study examines the effect of daily Coenzyme Q10 versus placebo(300mg daily with the same pills), administered throughout paclitaxel chemotherapy in breast cancer, on the incidence and severity of peripheral neuropathy and quality of life promotion. Neuropathy is evaluated pre- and post-treatment using questionnaires and Electrodiagnostic tests(NCS), with weekly assessments of quality of life and treatment side effects using EORTC-QLQ-CIPN20 and NCI-CTCAE v5.0.

Incidence of peripheral neuropathy, severity of peripheral neuropathy, quality of life promotion, and frequency of treatment-related adverse events، all compared between the intervention and control groups

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.

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.