Overview

GM1 Prophylaxis for WBRT Related Cognitive Dysfunction

Status:
Recruiting
Trial end date:
2023-05-31
Target enrollment:
Participant gender:
Summary
To evaluate the efficacy and safety of GM1 for preventing cognitive impairment related to whole brain radiotherapy in breast cancer patients with brain metastases. And explore the clinical and molecular parameter for predicting severe cognitive impairment induced by WBRT and gaining benefit from GM1. Primary Endpoint: the change of Hopkins Verbal and Learning Test-Revised Delayed Recall,HVLT-R DR,before and after WBRT Secondary ENDPOINT: the change of Alzheimer's Disease Assessment Scale-Cognitive,ADAS-Cog before and after WBRT;severe cognitive impairment percentage and onset time; Design:204 patients will be randomly assigned to exp.group,102 cases,and 102 cases of control group.
Phase:
Phase 3
Details
Lead Sponsor:
Sun Yat-sen University