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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239663
• Other study ID #: SYSUCC-016
• Status: Recruiting
• Phase: Phase 3
• Start date: February 8, 2022
• Est. completion date: February 8, 2024

Study information

• Verified date: March 2022
• Source: Sun Yat-sen University
• Contact: Zhongyu Yuan, Professor
• Phone: +862087343794
• Email: yuanzhy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy-Related Cognitive Impairment
• Cognitive Dysfunction

Intervention

Drug:
• Ganglioside-Monosialic Acid
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)
• 250ml normal saline (NS)
Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus 250ml normal saline (NS)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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