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

• Status: Recruiting
• Trial end date: 2024-02-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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.