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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chemotherapy-Related Cognitive Impairment Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

Ganglioside-Monosialic Acid

Intervention Type 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)

Control group

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

Group Type OTHER

250ml normal saline (NS)

Intervention Type DRUG

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

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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neuroprotective agents placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No