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 range18 Years – 75 Years
SexALL
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;
✓. 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;
What they're measuring
1
HVLT R-DR
Timeframe: 4 weeks after the completion of adjuvant chemotherapy