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

Sun Yat-sen University

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer; Chemotherapy-Related Cognitive Impairment

Treatments: Drug: Ganglioside-Monosialic Acid; Drug: 250ml normal saline (NS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05239663

SYSUCC-016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

experimental group

Experimental group

Description:

standard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS)

Treatment:

Drug: Ganglioside-Monosialic Acid

Control group

Other group

Description:

standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS)

Treatment:

Drug: 250ml normal saline (NS)