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A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00659269
First Posted: April 16, 2008
Last Update Posted: February 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
Results First Submitted: June 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Cancer
Interventions: Dietary Supplement: Multivitamin (MV)
Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6
Drug: Chemotherapy

  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
Subjects were recruited between July, 2006, and September, 2013, at participating cancer clinics across the state of New Mexico

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
Multivitamin (MV)

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Multivitamin + Vitamin B12 + Vitamin B6

Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

  1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
  2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Cumulative doses (in mg/m2) are:

paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400


Participant Flow:   Overall Study
    Multivitamin (MV)   Multivitamin + Vitamin B12 + Vitamin B6
STARTED   157   162 
Group 1 (Heavy Metals)   52   52 
Group 2 (Vinca Alkaloids)   12   12 
Group 3 (Taxanes)   92   97 
COMPLETED   156   161 
NOT COMPLETED   1   1 
Physician Decision                1                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.
No text entered.

Reporting Groups
  Description
Multivitamin (MV)

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Multivitamin + Vitamin B12 + Vitamin B6

Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

  1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
  2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Cumulative doses (in mg/m2) are:

paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400

Total Total of all reporting groups

Baseline Measures
   Multivitamin (MV)   Multivitamin + Vitamin B12 + Vitamin B6   Total 
Overall Participants Analyzed 
[Units: Participants]
 157   162   319 
Age 
[Units: Years]
Median (Full Range)
 56 
 (23 to 83) 
 54.5 
 (18 to 80) 
 55 
 (18 to 83) 
Gender 
[Units: Participants]
     
Female   114   116   230 
Male   43   46   89 
Region of Enrollment 
[Units: Participants]
     
United States   157   162   319 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Neurotoxicity Assessment at Baseline   [ Time Frame: At study start; prior to treatment (week 0) ]

2.  Primary:   Neurotoxicity Assessment at Cycle 2   [ Time Frame: 2 weeks ]

3.  Primary:   Neurotoxicity Assessment at Cycle 4   [ Time Frame: 4 weeks ]

4.  Primary:   Change in Neurotoxicity Assessment Between Cycle 4 and Baseline   [ Time Frame: 4 weeks ]


  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
The number of completed surveys decreased as time went on for each group of patients. This resulted in small numbers of patients to analyze, especially in Group 3 (Vinca Alkaloids), since there weren't many patients in this group to begin with.


  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: Zoneddy Dayao, MD
Organization: University of New Mexico
phone: 5059250404
e-mail: zdayao@salud.unm.edu



Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00659269     History of Changes
Other Study ID Numbers: INST 0553C
NCI-2012-00946 ( Registry Identifier: National Cancer Institute CTRP )
First Submitted: April 14, 2008
First Posted: April 16, 2008
Results First Submitted: June 18, 2015
Results First Posted: January 25, 2016
Last Update Posted: February 26, 2016