GM1 Prophylaxis for WBRT Related Cognitive Dysfunction

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• Age between 18-75,with histological affirmative breast cancer ,and over 4 brain metastases ,need for WBRT suggested by radiotherapy oncologist ;

• Estimated survival time over 6months;

• Abundant hematological function:Absolute Neutrophil Count≥2×109/L ;platelet count≥100×109/L and hemoglobulin≥9 g/dL;

• Abundant liver function：total bilrubin≤ULN；ASTandALT≤2.5ULN；AKP≤5ULN

• Can cope with HVLT-RDR and ADAS-Cog evaluation

• No prior therapy could induce neurological damage,within 4 weeks

• No more that 1 degree peripheral neuropathy or any other diseases or symptoms that could hinder the evaluation of neurological AE

• No more treatment or nursing is allowed after enrolling this trail

• Written Informed Consent signed

Exclusion Criteria:

• PS score over 2,and estimated no attenuation by WBRT

• Women with pregnancy or breast feeding

• Unwilling to contraception measurement

• Abnormal baseline impairment of cognitive impairment

• Allergy to experiment agents or components

• Unsuitable to GM1 treatment, evaluated by investigators

• Active infection

• RT dose over 30Gy