Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity

Phase 3

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Calcium and Magnesium; Drug: Glutamine

• Registration Number: NCT01087658
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To assess the benefit of glutamine when added to calcium-magnesium on the occurrence of grade 2, 3 and 4 peripheral sensory neuropathy (PSN) related to oxaliplatin with the National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) scale taking into account the time from start of oxaliplatin at which the first event occurred.

Secondary Objective:

To determine cumulative dose of oxaliplatin and time when the first occurrence of grade 2, 3 or 4 PSN.

To determine the incidence of dose-reductions, dose-delays and discontinuations of oxaliplatin due to PSN grade 3 or 4.

To assess effects of glutamine when added to calcium-magnesium on patients-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12 items questionnaire (FACT/GOG NTX-12) subscale.

To evaluate the incidence of diarrhea. To determine Progression Free Survival (PFS) in metastatic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium magnesium	Calcium and Magnesium	1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion. All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.
Glutamine and calcium magnesium	Calcium and Magnesium	Glutamine 10g p.o. 3-times a day beginning at day -2 for 7 consecutive days during each chemotherapy cycle. 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion. All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.
Glutamine and calcium magnesium	Glutamine	Glutamine 10g p.o. 3-times a day beginning at day -2 for 7 consecutive days during each chemotherapy cycle. 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion. All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6.

Primary Outcome Measures

Name	Time	Method
Occurence of peripheral sensory neuropathy (PSN) grade 2, 3 and 4 assessed by the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE)	Every cycle i.e. 2 or 3 weeks according to the treatment arm

Secondary Outcome Measures

Name	Time	Method
Cumulative dose of oxaliplatin and time of onset when the first PSN grade 2, 3 or 4 occurs	Every cycle i.e. 2 or 3 weeks according to the treatment arm
Dose-reduction, dose-delay and discontinuation of oxaliplatin due to PSN grade 3 or 4	Every cycle i.e. 2 or 3 weeks according to the treatment arm
Patient self-reported neurotoxicity scale for chronic peripheral neuropathy	Every cycle i.e. 2 or 3 weeks according to the treatment arm
Progression Free Survival / PFS (for metastatic patients)	Every cycle i.e. 2 or 3 weeks according to the treatment arm

Trial Locations

Locations (14)

Investigational Site Number 0001; 🇨🇦 Greenfield Park, Canada

Investigational Site Number 124-011; 🇨🇦 Montreal, Canada

Investigational Site Number 124-003; 🇨🇦 Quebec, Canada

Investigational Site Number 124-014; 🇨🇦 Moncton, Canada

Investigational Site Number 124-006; 🇨🇦 Montreal, Canada

Investigational Site Number 124-004; 🇨🇦 Montreal, Canada

Investigational Site Number 124010; 🇨🇦 Montreal, Canada

Investigational Site Number 124-017; 🇨🇦 Rimouski, Canada

Investigational Site Number 124-002; 🇨🇦 Toronto, Canada

Investigational Site Number 124-015; 🇨🇦 Oshawa, Canada

Investigational Site Number 124-005; 🇨🇦 Laval, Canada

Investigational Site Number 124-007; 🇨🇦 London, Canada

Investigational Site Number 124-012; 🇨🇦 Ottawa, Canada

Investigational Site Number 124-016; 🇨🇦 Winnipeg, Canada