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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Chemotherapy-Related Cognitive Impairment
• Intervention / Treatment: Drug: Ganglioside-Monosialic Acid; Drug: 250ml normal saline (NS)

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhongyu Yuan, Professor; Phone Number: +862087343794; Email: yuanzhy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Zhongyu Yuan, Professor; Phone Number: +862087343794; Email: yuanzhy@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; standard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS)	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)
Other: Control group; standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS)	Drug: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Anticipated): February 8, 2024
• Study Completion (Anticipated): February 8, 2024

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 13, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Skin Diseases; Neoplasms; Neoplasms by Site; Neurocognitive Disorders; Breast Diseases; Cognition Disorders; Drug-Related Side Effects and Adverse Reactions; Breast Neoplasms; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment
• Other Study ID Numbers: SYSUCC-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No