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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00659269
First received: April 14, 2008
Last updated: December 16, 2015
Last verified: December 2015
Results First Received: June 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: 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  
Number of Participants  
[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
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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


No publications provided


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 )
Study First Received: April 14, 2008
Results First Received: June 18, 2015
Last Updated: December 16, 2015
Health Authority: United States: Institutional Review Board