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L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

This study has been terminated.
(unable to accrue study participants)
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT00754767
First received: September 17, 2008
Last updated: August 10, 2017
Last verified: October 2015
Results First Received: March 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Chemotherapeutic Agent Toxicity
Neurotoxicity
Interventions: Drug: L-carnitine L-tartrate
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
oncology clinic

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

Reporting Groups
  Description
Arm I

Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

L-carnitine L-tartrate: Given orally

Arm II

Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

placebo: Given orally


Participant Flow:   Overall Study
    Arm I   Arm II
STARTED   2   0 
COMPLETED   2   0 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Arm I

Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

L-carnitine L-tartrate: Given orally

Arm II

Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

placebo: Given orally

Total Total of all reporting groups

Baseline Measures
   Arm I   Arm II   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   0   2 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 2   0   2 
<=18 years      0   0.0%   0      0   0.0% 
Between 18 and 65 years      2 100.0%   0      2 100.0% 
>=65 years      0   0.0%   0      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 2   0   2 
Female      2 100.0%   0      2 100.0% 
Male      0   0.0%   0      0   0.0% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment [1] 
[Units: Participants]
        
[1] data was not analyzed due to study termination


  Outcome Measures

1.  Primary:   Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork   [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ]


  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
No text entered.


  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. Alice Shapiro
Organization: HealthPartnersInstitute
phone: 952-993-1704
e-mail: shapia@parknicollet.com



Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00754767     History of Changes
Other Study ID Numbers: CDR0000614311
PNCC-03312-05-C
UMN-0508M72428
Study First Received: September 17, 2008
Results First Received: March 1, 2017
Last Updated: August 10, 2017