Monosialotetrahexosylganglioside for Treatment of Oxaliplatin Induced Neurotoxicity in Gastrointestinal Cancer

NCT02486198 | Completed Phase 3 DMC

• 1 other identifier: TianjinCIH20141201
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurotoxicity

Keywords

Gastrointestinal cancer; oxaliplatin; neurotoxicity

Outcome Measures

Primary Outcomes (1)

• The relief of neurotoxicity in patients with grade 2 or higher neurotoxicity by means of CTC 4.03 and EORTC QLQ-CIPN20

  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 Outcomes (2)

• Safety of Monosialotetrahexosylganglioside sodium injection in treatment of Oxaliplatin induced Neurotoxicity in Gastrointestinal cancer as measured by the number of any adverse effect

  every 2 or 3 weeks during GM usage and will continue to assess every 3 months, up to 1 year

• 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

Study Arms (2)

placebo+oxaliplatin-based chemotherapy

PLACEBO COMPARATOR

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; Drug: oxaliplatin-based chemotherapy

GM+oxaliplatin-based chemotherapy

EXPERIMENTAL

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; Drug: oxaliplatin-based chemotherapy

Interventions

placebo DRUG

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)

Also known as: Saline

placebo+oxaliplatin-based chemotherapy

GM DRUG

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)

Also known as: Brand name: shenjie

GM+oxaliplatin-based chemotherapy

oxaliplatin-based chemotherapy DRUG

chemotherapy contains oxaliplatin

Also known as: eloxatin,aiheng

GM+oxaliplatin-based chemotherapy; placebo+oxaliplatin-based chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

TianjinCIH

Tianjin, Tianjin Municipality, 300060, China

Location

Related Publications (1)

• Zhou L, Liu R, Huang D, Li H, Ning T, Zhang L, Ge S, Bai M, Wang X, Yang Y, Wang X, Chen X, Gao Z, Luo L, Yang Y, Wu X, Deng T, Ba Y. Monosialotetrahexosylganglioside in the treatment of chronic oxaliplatin-induced peripheral neurotoxicity: TJMUCH-GI-001, a randomised controlled trial. EClinicalMedicine. 2021 Oct 29;41:101157. doi: 10.1016/j.eclinm.2021.101157. eCollection 2021 Nov.

  PMID: 34765950 DERIVED

MeSH Terms

Conditions

Neurotoxicity Syndromes; Gastrointestinal Neoplasms

Interventions

Sodium Chloride; Oxaliplatin

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Yi Ba, MD.PHD

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2015
• First Posted: July 1, 2015
• Study Start: May 5, 2015
• Primary Completion: January 11, 2018
• Study Completion: February 2, 2018
• Last Updated: February 5, 2018

Record last verified: 2015-05

Locations

CN (1)