Clinical trial · Interventional
GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial
NCT05239663CI-TRIAL-00079367terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty accruing subjects the study accrual was closed
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-Related Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 250ml normal saline (NS) | Drug | — | UNRESOLVED |
| Ganglioside-Monosialic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- standard (neo)adjuvant chemotherapy plus Ganglioside-Monosialic Acid 100mg+250ml normal saline (NS)
- interventionNames
- Drug: Ganglioside-Monosialic Acid
- type
- OTHER
- label
- Control group
- description
- standard (neo)adjuvant chemotherapy plus 250ml normal saline (NS)
- interventionNames
- Drug: 250ml normal saline (NS)
Primary outcomes (1)
- measure
- HVLT R-DR
- timeFrame
- 4 weeks after the completion of adjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.