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NCT Number: NCT02251977

Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer

The primary objective of this study is to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

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Key information

Conditions

Colorectal Cancer Chemotherapy-induced Neutropenia Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

Oxaliplatin is a key agent in the treatment of colorectal cancer. However, peripheral neuropathy markedly limits the use of oxaliplatin. Many drugs have been tried to decrease the development of oxaliplatin induced peripheral neurotoxicity, however, the results remain disappointing. This multi-center, randomized, placebo-controlled trial was performed to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-75 years old, male or female
  • Histologically confirmed diagnosis of colorectal adenocarcinoma with a phase II or III disease, within 2 months from radical resection, and intends to receive 6 months of adjuvant chemotherapy with mFOLOFX6 or XELOX, without adjuvant radiation indications
  • No prior any level of peripheral nerve system disease
  • Patients have not received any other possible neurotoxic-reaction-causing drugs (such as oxaliplatin, cisplatin and paclitaxel drugs etc)
  • With the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
  • With normal functions of major organs
  • No contraindication to chemotherapy
  • Life expectancy ≥ 3 months
  • Patients have provided a signed Informed Consent Form

Exclusion criteria

  • Patients who received radical resection, but are expected not be able to complete 6 months of adjuvant chemotherapy
  • Patients who receive palliative chemotherapy
  • Patients who need adjuvant or palliative radiotherapy during chemotherapy
  • Be allergic to GM1
  • Hereditary abnormal metabolism of glucose and lipid
  • Doctors believe that patients are not suitable for receiving GM1 treatment
  • With confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
  • With concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
  • Patients (male or female) have fertility possibility but not willing or not to take effective contraceptive measures

Treatment and study plan

GM1

Drug

GM1 will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of GM1 for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.

Other names: monosialotetrahexosylganglioside

Placebo

Drug

Placebo will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of placebo for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.

mFOLFOX6 or XELOX

Drug

mFOLFOX6: Patients will receive mFOLFOX6 every 14 days, Oxaliplatin 85mg/m2 IV over 3 hours on Day1; Calcium Folinate IV over 2h on Day 1(Leucovorin 200mg/m2 or CF 400 mg/m2); 5-Fluorouracil 400mg/m2 IV on Day1; followed by 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day1.

XELOX: Patients will receive XELOX every 21 days, Oxaliplatin 130mg/m2 IV over 3 hours on Day1;followed by Capecitabine 1000mg/m2 oral twice daily for 14 days.

The optimum chemotherapy regimen is at the discretion of the investigators based on the condition of each patient.

Other names: Oxalipaltin, Leucovorin, Calcium Folinate, 5-Fluorouracil, Capecitabine

Primary outcomes

  1. rates of grade 2 or more chronic cumulative neurotoxicity of both arms

    Time frame: 9 months

    measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, with standardized questions regarding neurotoxic symptoms and examples of answers

Secondary outcomes

  1. rates of chronic cumulative neurotoxicity of both arms

    Time frame: 9 months

    measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20

  2. time to grade 2 or more neurotoxicity of both arms

    Time frame: 9 months

  3. rates of dose reduction or withdrawal due to oxaliplatin induced neurotoxicity of both arms

    Time frame: 9 months

  4. rates of acute neurotoxicity of both arms

    Time frame: 6 months

    measured by a numerical analog scale ranging from 0 to 10 that addressed sensitivity touching cold items, discomfort swallowing cold items, throat discomfort, and muscle cramps

  5. rates and grades of adverse reactions of both arms

    Time frame: 6 months

  6. rates of 3 year disease free survival of both arms

    Time frame: 3 years

Other outcomes

  1. change degrees of the levels of nerve growth factor and other neurotrophic factors of both arms

    Time frame: 6 months

  2. genetic polymorphisms of oxaliplatin induced severe and cumulative neurotoxicity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Yuhong Li

Other

Registry information

Official study title

The Effect of Monosialotetrahexosylganglioside (GM1) in Prevention of Oxaliplatin Induced Neurotoxicity in Colorectal Cancer Patients Who Received Oxaliplatin-based Adjuvant Chemotherapy: A Multi-center, Randomized, Placebo-controlled Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 29, 2014
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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