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Trial record 13 of 1979 for:    oxaliplatin

Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

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ClinicalTrials.gov Identifier: NCT02486198
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
The purpose of this study is to determine whether Monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in GI cancer.

Condition or disease Intervention/treatment Phase
Neurotoxicity Drug: placebo Drug: GM Drug: oxaliplatin-based chemotherapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Monosialotetrahexosylganglioside Sodium Injection for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer
Actual Study Start Date : May 5, 2015
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : February 2, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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.
Drug: placebo
  1. For patients with oxaliplatin-based chemotherapy(every 2 or 3 weeks), equal saline as placebo should be used one hour before oxaliplatin for 1 week during every chemotherapy cycle, until neurotoxicity progressed.
  2. For patients who discontinue oxaliplatin-based chemotherapy, equal saline as placebo should be used daily until there is no neurotoxicity relief (neurotoxicity should be assessed at 2 and 4 weeks' treatment, up to 18 weeks)
Other Name: Saline

Drug: oxaliplatin-based chemotherapy
chemotherapy contains oxaliplatin
Other Name: eloxatin,aiheng

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.
Drug: GM
  1. For patients with oxaliplatin-based chemotherapy(every 2 or 3 weeks), monosialotetrahexosylganglioside sodium injection(40mg for chemotherapy of every 2 weeks or 60mg for chemotherapy of every 3 weeks)should be used one hour before oxaliplatin for 1 week during every chemotherapy cycle, until neurotoxicity progressed.
  2. For patients who discontinue oxaliplatin-based chemotherapy, equal monosialotetrahexosylganglioside sodium injection should be used daily until there is no neurotoxicity relief (neurotoxicity should be assessed at 2 and 4 weeks' treatment, up to 18 weeks)
Other Name: Brand name: shenjie

Drug: oxaliplatin-based chemotherapy
chemotherapy contains oxaliplatin
Other Name: eloxatin,aiheng




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;
  2. male or female age >18 years old;
  3. diagnosis GI cancer with histology;
  4. Chronic neurotoxicity grade is 2 or more
  5. Karnofsky Performance scores should be 80 or more
  6. patients are in oxaliplatin-based chemotherapy courses or no more than 21 days after last oxaliplatin usage for patients who will discontinue oxaliplatin usage.
  7. without uncured tumor except GI cancer,
  8. Patients should be expected to live no shorter than 3 months

Exclusion Criteria:

  1. patients who is receiving anti-neurotoxicity treatment;
  2. 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);
  3. heart dysfunction;
  4. brain metastasis with symptoms;
  5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
  6. in situation of oxaliplatin-based chemotherapy progressed, the next chemotherapy regime should not contain agents which will cause neurotoxicity (such as paclitaxel and cisplatin)

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): NCT02486198


Locations
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China, Tianjin
TianjinCIH
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Principal Investigator: Yi Ba, MD.PHD Tianjin cancer hospital

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02486198     History of Changes
Other Study ID Numbers: TianjinCIH20141201
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: May 2015
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Gastrointestinal cancer
oxaliplatin
neurotoxicity
Additional relevant MeSH terms:
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Oxaliplatin
Gastrointestinal Neoplasms
Neurotoxicity Syndromes
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Antineoplastic Agents