The purpose of this study is to evaluate the prophylactic effects of Ganglioside-Monosialic Acid in post-chemotherapy cognitive impairment in patients with early operable breast cancer.
This is a multicenter, prospective, randomized, single-blind, phase III clinical trial. The primary endpoint is the changes of cognitive function from baseline to 4 weeks after the completion of adjuvant chemotherapy in the experimental group and the control group, which were evaluated by HVLT-R scale. This study is designed to recruit up to 306 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
76
Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS)
Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus 250ml normal saline (NS)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
HVLT R-DR
The change of score for Hopkins verbal learning test -revised,delayed recall,from baseline to 4 weeks after the completion of adjuvant chemotherapy.
Time frame: 4 weeks after the completion of adjuvant chemotherapy
HVLT R-DR
The change of score for Hopkins verbal learning test -revised,delayed recall,from baseline to 12 weeks,24 weeks and 36 weeks after the completion of adjuvant chemotherapy.
Time frame: 36 weeks after the completion of adjuvant chemotherapy
ADAS-Cog
The change of score for Alzheimer's Disease Assessment Scale-Cognitive,from baseline to 12 weeks,24 weeks and 36 weeks after the completion of adjuvant chemotherapy.
Time frame: 36 weeks after the completion of adjuvant chemotherapy
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