Back to resultsGM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
Primary Purpose
Chemotherapy-Related Cognitive Impairment, Breast Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ganglioside-Monosialic Acid
250ml normal saline (NS)
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-Related Cognitive Impairment focused on measuring Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
experimental group
Control group
Arm Description
standard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS)
standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05239663
First Posted
February 7, 2022
Last Updated
March 25, 2022
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05239663
Brief Title
GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
Official Title
The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
February 8, 2024 (Anticipated)
Study Completion Date
February 8, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Related Cognitive Impairment, Breast Cancer
Keywords
Ganglioside-Monosialic Acid, post-chemotherapy cognitive impairment, breast cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
standard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS)
Arm Title
Control group
Arm Type
Other
Arm Description
standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS)
Intervention Type
Drug
Intervention Name(s)
Ganglioside-Monosialic Acid
Intervention Description
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
Intervention Name(s)
250ml normal saline (NS)
Intervention Description
Standard (neo)adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus 250ml normal saline (NS)
Primary Outcome Measure Information:
Title
HVLT R-DR
Description
The change of score for Hopkins verbal learning test -revised,delayed recall,from baseline to 4 weeks after the completion of adjuvant chemotherapy.
Time Frame
4 weeks after the completion of adjuvant chemotherapy
Secondary Outcome Measure Information:
Title
HVLT R-DR
Description
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.
Time Frame
36 weeks after the completion of adjuvant chemotherapy
Title
ADAS-Cog
Description
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.
Time Frame
36 weeks after the completion of adjuvant chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongyu Yuan, Professor
Phone
+862087343794
Email
yuanzhy@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongyu Yuan, Professor
Phone
+862087343794
Email
yuanzhy@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
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