Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer

This study has been terminated.
(Study was terminated due to lack of accrual)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00998738
First received: October 19, 2009
Last updated: July 26, 2013
Last verified: July 2013
Results First Received: May 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Stage IV Breast Cancer
Recurrent Breast Cancer
Interventions: Drug: calcium gluconate
Drug: magnesium sulfate
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One participant was recruited between November 2009 and July 2010 at Mayo Clinic. This trial was terminated in July 2010 due to lack of accrual. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Overall No text entered.

Participant Flow:   Overall Study
    Overall  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Uknown                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.

Reporting Groups
  Description
Overall No text entered.

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  0  
Age  
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<=18 years      
Between 18 and 65 years      
>=65 years      
Age  
[units: years]
Mean ± Standard Deviation
   
Gender  
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Female      
Male      
Region of Enrollment  
[units: participants]
 
United States      



  Outcome Measures
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1.  Primary:   Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20   [ Time Frame: During the first 18 weeks of ixabepilone-based therapy ]

2.  Secondary:   Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale   [ Time Frame: Up to 12 months from initiation of ixabepilone ]

3.  Secondary:   Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version   [ Time Frame: Up to 12 months from initiation of ixabepilone ]

4.  Secondary:   Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy   [ Time Frame: Up to 12 months from initiation of ixabepilone ]

5.  Secondary:   Average Cumulative Ixabepilone Dose   [ Time Frame: Up to 12 months from initiation of ixabepilone ]

6.  Secondary:   Toxicity Profile of CaMg Per CTCAE Active Version   [ Time Frame: Up to 12 months from initiation of ixabepilone ]

7.  Secondary:   Incidence of the Acute Pain Syndrome (APS)   [ Time Frame: Treatment initiation to day 21 (Cycle 1) ]

8.  Secondary:   Severity of the Acute Pain Syndrome (APS)   [ Time Frame: Treatment initiation to day 21 (Cycle 1) ]

9.  Secondary:   Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy   [ Time Frame: First cycle of therapy (up to 21 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Charles Loprinzi
Organization: Mayo Clinic
phone: 507-266-6247
e-mail: cloprinzi@mayo.edu


No publications provided


Responsible Party: Charles Loprinzi, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00998738     History of Changes
Other Study ID Numbers: RC08CC, NCI-2009-01229, 08-008811, CA163-195
Study First Received: October 19, 2009
Results First Received: May 16, 2013
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board