GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial

Conditions
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Chemotherapy-Related Cognitive Impairment, Breast Cancer

Intervention / Treatment
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* Drug: Ganglioside-Monosialic Acid
* Drug: 250ml normal saline (NS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have provided written and signed informed consent; Histologically confirmed invasive ductal carcinoma; Planned to received (neo)/adjuvant chemotherapy; Eastern Cooperative Oncology Group (ECOG) score of 0 to 1; Can cope with HVLT-RDR and ADAS-Cog evaluation; No prior therapy could induce neurological damage,within 4 weeks Normal blood routine, liver and kidney functions within 1 week before enrollment in this study; 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. Compliance with the study protocol. Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG) score ≥ 2; Hypersensitivity to experiment agents or components; Women with pregnancy or breast feeding; A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; Abnormal baseline impairment of cognitive impairment; Poor compliance, unwillingness or inability to follow protocol to continue the study; Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>standard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS) | Drug: Ganglioside-Monosialic Acid<br>* 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)<br>|
| Other: Control group<br>standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS) | Drug: 250ml normal saline (NS)<br>* Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus 250ml normal saline (NS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks after the completion of adjuvant chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 36 weeks after the completion of adjuvant chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer