2.1. Patients:
In our study, 236 patients who referred to the outpatient oncology
department of Emam Hospital, affiliated to Mazandaran University of
Medical Sciences were screened for enrollment. Eighty patients were
eligible for the study. Inclusion criteria were a histologically
confirmed diagnosis of cancer, at least 18 years of age, and occurrence
of CIPN.
Exclusion criteria were 1) any underlying diseases with manifestation of
neuropathy symptoms including diabetes, neuromuscular disease, vitamin
B12 deficiency, amyloidosis, and connective tissue disease, 2) patients
with a history of neurological diseases such as hereditary and acquired
neuropathies, 3) taking any antioxidant supplement in the last two
months, 4) pregnancy or breastfeeding, 4) known hypersensitivity to
silymarin. All participants gave their written informed consent.
Eligible patients were randomly assigned to treatment arms on a 1:1
basis.
The study was approved by the ethics committee of Mazandaran University
of Medical Sciences (IR.MAZUMS.IMAMHOSPITAL.REC.1398.6176) and
registered in Iranian Registry of Clinical Trials
(IRCT20201128049515N1). The trial was conducted according to the
guidelines of the Declaration of Helsinki for Research on Human Subjects
1989. Considering the effect size of 0.6, 95% confidence level and test
power of 80%, sample size was calculated 80 patients (40 cases in each
group) by G-Power software.