GM1 Prophylaxis for WBRT Related Cognitive Dysfunction

NCT04395339 | Terminated Phase 3 DMC

• 1 other identifier: SYSUCC-012
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Brain Metastases; Radiotherapy Side Effect; Cognitive Impairment; Gangliosidosis, GM1; Breast Cancer

Keywords

WBRT; Gangliosidoses; Brain Metastases; radiotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• HVLT R-DR

  The change of score for Hopkins verbal learning test -revised,delayed recall,form baseline to 24weeks after WBRT,score ranges from 0 to 12,higher score indicates better cognitive function

  24 weeks after WBRT.

Secondary Outcomes (2)

• ADAS-Cog

  24 weeks after WBRT.

• MMSE

  24 weeks after RT.

Study Arms (2)

Experimental arm(GM1)

EXPERIMENTAL

This arm will be treated with GM1.

Drug: Monosialotetrahexosyl ganglioside (GM1)

Control arm

PLACEBO COMPARATOR

This arm will be treat with blank placebo.

Drug: Control

Interventions

Monosialotetrahexosyl ganglioside (GM1) DRUG

Ganglioside-Monosialic Acid is added into 250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 15 days. The first dose is given at 1 day before the start of the radiotherapy.

Also known as: a group of galactose-containing cerebrosides found in the surface membranes of nerve cells

Experimental arm(GM1)

Control DRUG

250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 15 days. The first dose is given at 1 day before the start of the radiotherapy.

Also known as: 0.9% sodium chloride

Control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Brain Neoplasms; Radiation Injuries; Cognitive Dysfunction; Gangliosidosis, GM1; Breast Neoplasms; Gangliosidoses

Interventions

G(M1) Ganglioside; Sodium Chloride

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gangliosides; Acidic Glycosphingolipids; Glycosphingolipids; Glycolipids; Glycoconjugates; Carbohydrates; Lipids; Sphingolipids; Membrane Lipids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zhong-yu Yuan, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 20, 2020
• Study Start: May 15, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)