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

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ClinicalTrials.gov Identifier: NCT00659269
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : January 25, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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
Enrollment 319
Recruitment Details Subjects were recruited between July, 2006, and September, 2013, at participating cancer clinics across the state of New Mexico
Pre-assignment Details  
Arm/Group Title Multivitamin (MV) Multivitamin + Vitamin B12 + Vitamin B6
Hide Arm/Group Description

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, 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

Period Title: Overall Study
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
Reason Not Completed
Physician Decision             1             1
Arm/Group Title Multivitamin (MV) Multivitamin + Vitamin B12 + Vitamin B6 Total
Hide Arm/Group Description

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, 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 of all reporting groups
Overall Number of Baseline Participants 157 162 319
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 157 participants 162 participants 319 participants
56
(23 to 83)
54.5
(18 to 80)
55
(18 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 162 participants 319 participants
Female
114
  72.6%
116
  71.6%
230
  72.1%
Male
43
  27.4%
46
  28.4%
89
  27.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 157 participants 162 participants 319 participants
157 162 319
1.Primary Outcome
Title Neurotoxicity Assessment at Baseline
Hide Description Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.
Time Frame At study start; prior to treatment (week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)
Arm/Group Title Taxane Group: Multivitamin (MV) Arm Taxane Group: MV + Vitamin B12 + Vitamin B6 Heavy Metals Group: Multivitamin (MV) Arm Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm Vinca Alkaloids Group: Multivitamin (MV) Arm Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm
Hide Arm/Group Description:

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)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400

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)

Cumulative doses for chemotherapy (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

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)

Cumulative doses for chemotherapy (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Overall Number of Participants Analyzed 84 86 48 45 10 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.5  (8.5) 7.3  (7.3) 5.23  (5.86) 4.58  (5.34) 6.80  (5.09) 2.08  (2.02)
2.Primary Outcome
Title Neurotoxicity Assessment at Cycle 2
Hide Description Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 & 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 & 25 patients in Group 2 (Heavy Metals) and 9 & 10 patients in Group 3 (Vinca)
Arm/Group Title Taxane Group: Multivitamin (MV) Arm Taxane Group: MV + Vitamin B12 + Vitamin B6 Heavy Metals Group: Multivitamin (MV) Arm Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm Vinca Alkaloids Group: Multivitamin (MV) Arm Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm
Hide Arm/Group Description:

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)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

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.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

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)

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

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)

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Overall Number of Participants Analyzed 72 80 27 25 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.0  (10.9) 12.0  (9.9) 9.7  (5.99) 8.4  (7.16) 14.56  (12.9) 5.6  (6.59)
3.Primary Outcome
Title Neurotoxicity Assessment at Cycle 4
Hide Description Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 & 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 & 21 patients in Group 2 (Heavy Metals) and 6 & 9 patients in Group 3 (Vinca)
Arm/Group Title Taxane Group: Multivitamin (MV) Arm Multivitamin + Vitamin B12 + Vitamin B6 Heavy Metals Group: Multivitamin (MV) Arm Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm Vinca Alkaloids Group: Multivitamin (MV) Arm Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm
Hide Arm/Group Description:

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)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

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)

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

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)

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Overall Number of Participants Analyzed 67 58 28 21 6 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.5  (11.4) 14.5  (11.1) 8.71  (6.5) 7.05  (6.55) 17.5  (5.36) 9.22  (10.22)
4.Primary Outcome
Title Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
Hide Description Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 92 & 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 & 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 & 20 patients in Group 2 (Heavy Metals) and 5 & 9 patients in Group 3 (Vinca)
Arm/Group Title Taxane Group: Multivitamin (MV) Arm Taxane Group: MV + Vitamin B12 + Vitamin B6 Heavy Metals Group: Multivitamin (MV) Arm Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm Vinca Alkaloids Group: Multivitamin (MV) Arm Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm
Hide Arm/Group Description:

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)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, abraxane, 1200-1800

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.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

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)

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

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)

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Multivitamin (MV) 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.

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Overall Number of Participants Analyzed 54 62 28 20 5 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.0  (9.9) 7.2  (9.8) 3.9  (7.1) 4.7  (5.7) 11.8  (4.7) 7  (9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Taxane Group: Multivitamin (MV) Arm, Taxane Group: MV + Vitamin B12 + Vitamin B6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Since vitamin B6 and B12 are food supplements with only rare toxic effects, no toxicity will be recorded. Only serious adverse (SAE) will be reported, whether or not related to these vitamins.
 
Arm/Group Title Multivitamin (MV) Multivitamin + Vitamin B12 + Vitamin B6
Hide Arm/Group Description

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, 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

All-Cause Mortality
Multivitamin (MV) Multivitamin + Vitamin B12 + Vitamin B6
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Multivitamin (MV) Multivitamin + Vitamin B12 + Vitamin B6
Affected / at Risk (%) Affected / at Risk (%)
Total   0/157 (0.00%)   0/162 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Multivitamin (MV) Multivitamin + Vitamin B12 + Vitamin B6
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
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
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