Breast Cancer, Chemotherapy-Related Cognitive Impairment
Conditions
Keywords
Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer
Brief summary
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.
Detailed description
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.
Interventions
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)
DRUG250ml normal saline (NS)
Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus 250ml normal saline (NS)
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Have provided written and signed informed consent; 2. Histologically confirmed invasive ductal carcinoma; 3. Planned to received (neo)/adjuvant chemotherapy; 4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1; 5. Can cope with HVLT-RDR and ADAS-Cog evaluation; 6. No prior therapy could induce neurological damage,within 4 weeks 7. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study; 8. Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period. 9. Compliance with the study protocol.
Exclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) score ≥ 2; 2. Hypersensitivity to experiment agents or components; 3. Women with pregnancy or breast feeding; 4. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 5. Abnormal baseline impairment of cognitive impairment; 6. Poor compliance, unwillingness or inability to follow protocol to continue the study; 7. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HVLT R-DR | 4 weeks after the completion of adjuvant chemotherapy | The change of score for Hopkins verbal learning test -revised,delayed recall,from baseline to 4 weeks after the completion of adjuvant chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HVLT R-DR | 36 weeks after the completion of adjuvant chemotherapy | 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. |
| ADAS-Cog | 36 weeks after the completion of adjuvant chemotherapy | 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. |
Countries
China
Outcome results
None listed