The efficacy and safety of Silymarin in chemotherapy-induced peripheral neuropathy (CIPN): a randomized double-blind clinical trial study

The efficacy and safety of Silymarin in chemotherapy-induced peripheral neuropathy (CIPN)

Patients with historically confirmed diagnosis of cancer having CIPN who refer to the outpatient oncology department of Sari Hospital, Iran will receive Silymarin or placebo in groups of intervention and control, respectively, and quality of life, pain and neuropathy intensity will be assessed by Quality of life Questionnaire (EORTC QLQ), Visual Analogue Scale (VAS), and Common Terminology Criteria for Adverse Event (CTCAE) criteria, respectively.

This is a double-blind, placebo-controlled study on patients with confirmed diagnosis of cancer who are having CIPN. Patients and care provider are unaware of the type of interventions. The drug and placebo are coded in unknown bottles and will be handed to patients.

Inclusion criteria: patients with histologically confirmed diagnosis of cancer, at least 18 years of age, and having CIPN will be included in the study. Exclusion criteria: patients predisposing to neuropathy, including diabetes, neuromuscular disease, vitamin B12 deficiency, amyloidosis, and connective tissue disease, hereditary and acquired neuropathies, unbearable side effects of the drug or drug reaction, taking any antioxidant supplement in the last two months, pregnancy, or breastfeeding will be excluded from the study.

Interventional group will receive 140 mg/day of the silymarin (Gol daru, Iran) in two daily doses with 300 mg/day Gabapentin as a standard treatment for peripheral neuropathy, while the control group will receive 300 mg/day of Gabapentin with placebo (microcrystalline cellulose) every 12 hours per day. Both groups will receive the drug for 3 months.

Patient's neuropathy intensity after intervention base on CTCAE criterion.

Those patients who give consent to enter the study will be randomized into blocks of four and sequentially numbered. The randomization code will be held by a third party. Then they will be categorized in two groups of intervention (Silymarin + Gabapentin) and control (Placebo + Gabapentin). Silymarin and placebo will be kept in bottles with previously defined codes and will be handed to participants randomly.

This is randomized, double-blind study. Patients and care provider will not be aware of the type of medication (Silymarin or placebo). Patients will be coded randomly into groups of intervention and control separately and their data will be kept in a computer with password. Care provider and patients will not have access to any of these data. Silymarin and placebo will be put in bottles based on patient's code and then will be handed to care provider and then to the patients monthly with no mention to the type of the medicine. Blinding will be applied till the end of the study and statistic analysis.

There's no further information.