MedTrace Logo

Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery

NCT00316914 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2016-08-11

Study results available
· View outcomes & findings →

Summary

RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy.

PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage IV colorectal cancer that has been completely removed by surgery.

Conditions

Interventions

DRUG

calcium gluconate

Given IV

DRUG

magnesium sulfate

Given IV

OTHER

placebo

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Axel Grothey, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-01-31
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00316914 on ClinicalTrials.gov