- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02486198
Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer
February 2, 2018 updated by: Tianjin Medical University Cancer Institute and Hospital
Monosialotetrahexosylganglioside Sodium Injection for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer
The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Oxaliplatin is widely used in GI cancer.
Neutropenia and neurotoxicity are the most common adverse effects of oxaliplatin which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity.The continuous sense and/or motor abnormal reduce the quality of life.
To date, there is no a drug to treat oxaliplatin induced neurotoxicity.
Monosialotetrahexosylganglioside(GM) is a component of membrane of nerve cells.
Previous phase II clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity (OIN).
But it did not investigated for curing OIN in randomized control trial.
A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for treatment OIN at GI cancer.
Investigators design this randomized phase III placebo-controlled trail to identify the effect of monosialotetrahexosylganglioside sodium injection as a treatment agent for OIN.
Investigators found 2.5% patients of grade 2 or more serious OIN would relieve with 3 months(data not published).
Investigators assume monosialotetrahexosylganglioside can reduce neurotoxicity by 30%.
At the level of power 0.8, the sample size is 160 with 10% dropout.
If there is no dropout, the trial will be terminated at 144 events occur.The board of Tianjin cancer hospital has permitted the trial and will monitor the whole process of this study.
All data will be submitted to the department of clinic trials at Tianjin cancer hospital.The statistics specialist is participating this design and will afford help for data analysis.
Study Type
Interventional
Enrollment (Actual)
145
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- TianjinCIH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients shall have normal organic function such as liver function, Cardiac function and renal function;
- male or female age >18 years old;
- diagnosis GI cancer with histology;
- Chronic neurotoxicity grade is 2 or more
- Karnofsky Performance scores should be 80 or more
- patients are in oxaliplatin-based chemotherapy courses or no more than 21 days after last oxaliplatin usage for patients who will discontinue oxaliplatin usage.
- without uncured tumor except GI cancer,
- Patients should be expected to live no shorter than 3 months
Exclusion Criteria:
- patients who is receiving anti-neurotoxicity treatment;
- WBC<4.0×109/L,ANC<1.5×109/L,PLT<100×109/L,Hb<90g/L,TBIL>1.5Limitation;BUN)>1.5Limitation;Cr)>1.5Limitation;ALT or AST>2.5Limitation(without liver metastasis);ALT or AST)>5Limitation(with liver metastasis);
- heart dysfunction;
- brain metastasis with symptoms;
- peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
- in situation of oxaliplatin-based chemotherapy progressed, the next chemotherapy regime should not contain agents which will cause neurotoxicity (such as paclitaxel and cisplatin)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo+oxaliplatin-based chemotherapy
equal saline as placebo, one hour before chemotherapy (if with chemotherapy) with oxaliplatin-based chemotherapy (every 2 or 3 weeks), or daily use until neurotoxicity progress.
|
Other Names:
chemotherapy contains oxaliplatin
Other Names:
|
Experimental: GM+oxaliplatin-based chemotherapy
monosialotetrahexosylganglioside Sodium Injection, 40mg or 60mg, one hour before chemotherapy (if with chemotherapy) with oxaliplatin-based chemotherapy (every 2 or 3 weeks), or daily use until neurotoxicity progress.
|
chemotherapy contains oxaliplatin
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The relief of neurotoxicity in patients with grade 2 or higher neurotoxicity by means of CTC 4.03 and EORTC QLQ-CIPN20
Time Frame: From the time recruited to neurotoxicity progressed(assesse before chemotherapy) or without relief(assess at week 2 and 4, up to 18 weeks)
|
Besides CTC 4.03 and modified EORTC QLQ-CIPN20, patients will evaluate the neurotoxicity relief extent on the Visual Analog Scale
|
From the time recruited to neurotoxicity progressed(assesse before chemotherapy) or without relief(assess at week 2 and 4, up to 18 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Monosialotetrahexosylganglioside sodium injection in treatment of Oxaliplatin induced Neurotoxicity in Gastrointestinal cancer as measured by the number of any adverse effect
Time Frame: every 2 or 3 weeks during GM usage and will continue to assess every 3 months, up to 1 year
|
The number of any adverse effect will be used to assess safety
|
every 2 or 3 weeks during GM usage and will continue to assess every 3 months, up to 1 year
|
quality of life
Time Frame: evaluate 1 week before interventions'usage and every 4 weeks , up to 24 weeks. And evaluate once within 4 weeks after the patients out of the study
|
investigators use sf-36 to evaluated the quality of life
|
evaluate 1 week before interventions'usage and every 4 weeks , up to 24 weeks. And evaluate once within 4 weeks after the patients out of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yi Ba, MD.PHD, Tianjin Cancer Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2015
Primary Completion (Actual)
January 11, 2018
Study Completion (Actual)
February 2, 2018
Study Registration Dates
First Submitted
May 3, 2015
First Submitted That Met QC Criteria
June 30, 2015
First Posted (Estimate)
July 1, 2015
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
February 2, 2018
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TianjinCIH20141201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurotoxicity
-
Ministry of Public Health, Democratic Republic...National Institutes of Health (NIH); Oregon Health and Science University; National... and other collaboratorsCompletedNeurotoxicity Syndrome, Cassava | Neurotoxicity Syndrome, Cyanate | Neurotoxicity Syndrome, Cyanide | Neurotoxicity Syndrome, ThiocyanateCongo, The Democratic Republic of the
-
Seoul National University HospitalActive, not recruitingAnesthesia and NeurotoxicityKorea, Republic of
-
Universitas Sumatera UtaraCompleted
-
Baylor College of MedicineCompletedSeizures | Development Delay | Anesthetic NeurotoxicityUnited States
-
zhang shoulongChanghai Hospital; Jinan Military General HospitalRecruitingImmune Effector Cell Associated Neurotoxicity SyndromeChina
-
M.D. Anderson Cancer CenterNot yet recruitingNeurotoxicityUnited States
-
University of Medicine and Dentistry of New JerseyTerminatedNeurotoxicity SyndromesUnited States
-
Gerald Higa, PharmD.TerminatedNeurotoxicityUnited States
-
National Cheng-Kung University HospitalActive, not recruitingNeurotoxicity SyndromesTaiwan
-
Oulu University HospitalUnknown
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States