Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in Advanced Gastric Cancer

Tianjin Medical University

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: monosialotetrahexosylganglioside Sodium; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02024438

20131201

Details and patient eligibility

About

For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for chemotherapy. 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. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at gastric cancer.

Full description

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 metastatic colorectal cancer with histology;
4. Did not received first-line chemotherapy
5. Karnofsky Performance scores should be 60,70,or80
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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

placebo

Other group

Description:

arm B: equal saline as placebo ,one hour before chemotherapy(mFOLFOX6) every two weeks until tumor progress or intolerant

Treatment:

Other: placebo

monosialotetrahexosylganglioside Sodium

Experimental group

Description:

arm A: monosialotetrahexosylganglioside Sodium Injection, 40mg,one hour before chemotherapy(mFOLFOX6), every two weeks until tumor progress or patients become intolerant

Treatment:

Drug: monosialotetrahexosylganglioside Sodium