Status:
TERMINATED
GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Chemotherapy-Related Cognitive Impairment
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 adjuv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05239663
Start Date
February 8 2022
End Date
July 31 2024
Last Update
August 1 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060