Status:
TERMINATED
GM1 Prophylaxis for WBRT Related Cognitive Dysfunction
Lead Sponsor:
Sun Yat-sen University
Conditions:
Brain Metastases
Radiotherapy Side Effect
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 molecul...
Detailed Description
Background:Brain metastasis is a common event for advanced stage cancer,and whole brain radiotherapy(WBRT)is one of the most effective and widely utilized measures for brain metastases.Gaining control...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04395339
Start Date
May 15 2020
End Date
July 31 2024
Last Update
August 1 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000