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

NCT05239663 | Terminated Phase 3 DMC

• 1 other identifier: SYSUCC-016
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-Related Cognitive Impairment; Breast Cancer

Keywords

Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• HVLT R-DR

  36 weeks after the completion of adjuvant chemotherapy

• ADAS-Cog

  36 weeks after the completion of adjuvant chemotherapy

Study Arms (2)

experimental group

EXPERIMENTAL

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

Drug: Ganglioside-Monosialic Acid

Control group

OTHER

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

Drug: 250ml normal saline (NS)

Interventions

Ganglioside-Monosialic Acid DRUG

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)

Also known as: neuroprotective agents

experimental group

250ml normal saline (NS) DRUG

Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus 250ml normal saline (NS)

Also known as: placebo

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment; Breast Neoplasms

Interventions

Neuroprotective Agents; Saline Solution

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 15, 2022
• Study Start: February 8, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)