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GM1 Prophylaxis for WBRT Related Cognitive Dysfunction (GLORY)

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ClinicalTrials.gov Identifier: NCT04395339
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Brain Metastases Radiotherapy Side Effect Cognitive Impairment Gangliosidosis, GM1 Breast Cancer Drug: Monosialotetrahexosyl ganglioside (GM1) Drug: Control Phase 3

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 of the brain metastases may provide better survival for patients,but can also cause cognitive impairment,sometimes may be severe.Considering cognitive function is one of the most important aspect of quality of life(QoL), some remedies for the treatment-related adverse effect should be provided. Some agents were evaluated for this purpose,and results were unsatisfying. Ganglioside-Monosialic Acid (GM1) is used as an neuroprotective agent after brain surgery or neurodegenerative disease,and a clinical trail(NCT02468739) hosted by our team demonstrated that it could relief taxane-induced neurotoxicity.So GM1 is proposedto be effective in treating WBRT related cognitive dysfunction.

Outline:This will be an single-blind,randomized study,102 patients planning to receive WBRT will be allocated to control and experiment group,respectively,to receive GM1(100mg D0-D14) or placebo(0.9% saline).Cognitive scales will be utilized to evaluate the efficacy.

PRIMARY OBJECTIVE:

Evaluate the efficacy of GM1 in alleviating WBRT related cognitive impairment by Hopkins Verbal and Learning Test Revised-Delayed Recall(HVLT-R DR) before and after RT.

Secondary Objective:

Evaluate the efficacy of GM1 in alleviating WBRT related cognitive impairment by Alzheimer's Disease Assessment Scale-Cognitive(ADAS-Cog )before and after RT.

Evaluate the efficacy of GM1 in alleviating WBRT related cognitive impairment by Mini-mental state Examination(MMSE)before and after RT.

Evaluate the efficacy of GM1 in alleviating WBRT related cognitive impairment by comparing severe cognitive impairment incidence,and onset time of cognitive dysfunction.

Explore the molecular parameter for GM1 benefit. Treatment group: 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. At the same time, the patients are treated with a WBRT protocol selected by the investigators.

Placebo group: Placebo is 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 RT. At the same time, the patients are treated with a WBRT protocol selected by the investigators.

Follow up: Assessment will be performed before and 12,24 36,48 weeks after RT.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ganglioside-Monosialic Acid Prophylaxis for Cognitive Dysfunction Related to Whole Brain Radiotherapy in Breast Cancer Patients With Brain Metastases ，a Multi-center，Randomized，Single Blind，Phase III Clinical Trail
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental arm(GM1)
This arm will be treated with GM1.
 Drug: Monosialotetrahexosyl ganglioside (GM1)
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.
Other Name: a group of galactose-containing cerebrosides found in the surface membranes of nerve cells
Placebo Comparator: Control arm
This arm will be treat with blank placebo.
 Drug: Control
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.
Other Name: 0.9% sodium chloride


Outcome Measures
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Primary Outcome Measures :
  1. HVLT R-DR [ Time Frame: 24 weeks after WBRT. ]
    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


Secondary Outcome Measures :
  1. ADAS-Cog [ Time Frame: 24 weeks after WBRT. ]
    The change of score for Alzheimer's Disease Assessment Scale-Cognitive，ADAS-Cog,form baseline to 24 weeks after WBRT,score ranges from 0 to 75,LOWER score indicates better cognitive function

  2. MMSE [ Time Frame: 24 weeks after RT. ]
    The change of score for Minimal Mental State Examination,MMSE,form baseline to 24 weeks after WBRT,higher score indicates better cognitive function


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395339


Contacts
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Contact: Jiajia Huang, MD,PhD +86 02087343794 huangjiaj@sysucc.org.cn
Contact: Yongyi Zhong, BD +86 02087343794 ZHONGYY@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: zhongyu yuan, MD,PhD       YUANZHY@SYSUCC.ORG.CN   
Contact: yongyi zhong, BD       zhongyy@sysucc.org.cn   
Principal Investigator: Zhenyu he, MD,Phd         
Principal Investigator: Jiajia Huang, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zhong-yu Yuan, M.D. Sun Yat-sen University
More Information
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Responsible Party: Zhong-yu Yuan, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04395339    
Other Study ID Numbers: SYSUCC-012
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zhong-yu Yuan, Sun Yat-sen University:
WBRT
Gangliosidoses
Brain Metastases
radiotherapy
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Gangliosidoses
Gangliosidosis, GM1
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
 Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases