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Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02024412
Recruitment Status : Unknown
Verified September 2015 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : September 28, 2015
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
The morbidity of colorectal cancer(CRC) is 10%~15% in China.mFolfox6 has become one of the standard regimes for metastatic colorectal cancer (mCRC). Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse effects which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity. Monosialotetrahexosylganglioside 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 certificated by phase III trial. Investigators designed the phase III trial to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: monosialotetrahexosylganglioside Sodium Other: placebo Phase 3

Detailed Description:
it is a placebo controlled phase III trial. investigators plan to enroll 240 patients with 1:1 to A arm and B arm

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Safety and Effect of Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX6 as First-line Chemotherapy for Advanced Colorectal Cancer
Study Start Date : November 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: monosialotetrahexosylganglioside Sodium
arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant
Drug: monosialotetrahexosylganglioside Sodium
it is a component extract from pig's brain,shenjie is the brand name
Other Name: shenjie

Placebo Comparator: placebo
arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant
Other: placebo
saline of the same appearance as monosialotetrahexosylganglioside Sodium
Other Name: saline

Primary Outcome Measures :
  1. The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity [ Time Frame: From the first day of chemotherapy to 12 months after study or until one week before the patients receive second-line chemotherapy ]
    Acute neurotoxicity will be assessed the first day of oxaliplatin at every cycle given;accumulating neurotoxicity will be assessed every two weeks from the second day of first cycle until the patients out of the study. The accumulating neurotoxicity will be assessed every four weeks for 12 months or one week before second-line chemotherapy

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Eevery 6 weeks, up to 24 months ]
    Investigators assess the effect every six weeks and objective response is recorded as complete response,partial response or stable disease according to Recist 1.1

  2. Progress Free Survival [ Time Frame: investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months ]
    From date of randomization until the date of first documented progression

  3. overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 100 months ]
    the patients will be followed one month after progression ,then every 3 months,up to 100 months

  4. quality of life [ Time Frame: evaluate 1 week before chemotherapy and every 6 weeks of study. And evaluate within 4 weeks after the patients out of the study ]
    we use sf-36 to evaluated the quality of life

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients shall have normal organic function such as liver function, Cardiac function and renal function;
  2. age >18 years old;
  3. diagnosis mCRC with histology;
  4. Did not received first-line chemotherapy
  5. Karnofsky Performance scores >70 scores
  6. should have target lesions or non-target lesions
  7. For patients received oxaliplatin before, the residual neurotoxicity should less than grade 2
  8. For diabetes without neuropathy, blood glucose before meal should less than 8mmol/L and HBA1C<7.0%
  9. Patients should be expected to live no shorter than 3 months

Exclusion Criteria:

  1. patients who is receiving chemotherapy;
  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;
  5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy;
  6. patients who received Glutathione, acetylcysteine, calcium / magnesium, amifostine, carbamazepine, B vitamins, vitamin E within 30 days

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 identifier (NCT number): NCT02024412

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Contact: Yi Ba, MD PHD +86 02223340123-1051

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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: YI BA, MD PHD    +8602223340123-1051   
Sub-Investigator: Likun Zhou, MD         
Principal Investigator: yi ba, MD PHD         
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
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Study Director: Yi Ba, MD.PHD Tianjin Medical University Cancer Institute and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital Identifier: NCT02024412    
Other Study ID Numbers: 20131123
E2013109A ( Other Identifier: TianjinCIH )
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
metastatic colorectal cancer
monosialotetrahexosylganglioside Sodium Injection
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neurotoxicity Syndromes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nervous System Diseases
Chemically-Induced Disorders