Monosialotetrahexosylganglioside Sodium Injection for Prevention Neurotoxicity of mFOLFOX 6 in mCRC

NCT ID: NCT02024412

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-12-31

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.

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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

monosialotetrahexosylganglioside Sodium

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

Group Type: EXPERIMENTAL

monosialotetrahexosylganglioside Sodium

Intervention Type: DRUG

it is a component extract from pig's brain,shenjie is the brand name

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

saline of the same appearance as monosialotetrahexosylganglioside Sodium

Interventions

monosialotetrahexosylganglioside Sodium

it is a component extract from pig's brain,shenjie is the brand name

Intervention Type: DRUG

placebo

saline of the same appearance as monosialotetrahexosylganglioside Sodium

Intervention Type: OTHER

Other Intervention Names

shenjie; saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Ba, MD.PHD

Role: STUDY_DIRECTOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Ba, MD PHD

Role: CONTACT

zhobualing123@163.com

+86 02223340123-1051

Facility Contacts

YI BA, MD PHD

Role: primary

zhoubaling123@163.com

+8602223340123-1051

Other Identifiers

E2013109A

Identifier Type: OTHER

Identifier Source: secondary_id

20131123

Identifier Type: -

Identifier Source: org_study_id