GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast… (NCT05239663) | Clinical Trial Compass
TerminatedPhase 3
GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
Stopped: Difficulty accruing subjects the study accrual was closed
China76 participantsStarted 2022-02-08
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have provided written and signed informed consent;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HVLT R-DR
Timeframe: 4 weeks after the completion of adjuvant chemotherapy
. 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.
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.