Trial Outcomes & Findings for A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients (NCT NCT00659269)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

319 participants

Primary outcome timeframe

At study start; prior to treatment (week 0)

Results posted on

2016-02-26

Participant Flow

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

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	157	162
Overall Study Group 1 (Heavy Metals)	52	52
Overall Study Group 2 (Vinca Alkaloids)	12	12
Overall Study Group 3 (Taxanes)	92	97
Overall Study COMPLETED	156	161
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Physician Decision	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multivitamin (MV) n=157 Participants 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 n=162 Participants 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 n=319 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	54.5 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants	116 Participants n=7 Participants	230 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Region of Enrollment United States	157 participants n=5 Participants	162 participants n=7 Participants	319 participants n=5 Participants

PRIMARY outcome

Timeframe: At study start; prior to treatment (week 0)

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Taxane Group: Multivitamin (MV) Arm n=84 Participants 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	Taxane Group: MV + Vitamin B12 + Vitamin B6 n=86 Participants 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	Heavy Metals Group: Multivitamin (MV) Arm n=48 Participants 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	Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm n=45 Participants 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	Vinca Alkaloids Group: Multivitamin (MV) Arm n=10 Participants 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	Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm n=12 Participants 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
Neurotoxicity Assessment at Baseline	8.5 units on a scale Standard Deviation 8.5	7.3 units on a scale Standard Deviation 7.3	5.23 units on a scale Standard Deviation 5.86	4.58 units on a scale Standard Deviation 5.34	6.80 units on a scale Standard Deviation 5.09	2.08 units on a scale Standard Deviation 2.02

PRIMARY outcome

Timeframe: 2 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Taxane Group: Multivitamin (MV) Arm n=72 Participants 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	Taxane Group: MV + Vitamin B12 + Vitamin B6 n=80 Participants 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	Heavy Metals Group: Multivitamin (MV) Arm n=27 Participants 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	Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm n=25 Participants 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	Vinca Alkaloids Group: Multivitamin (MV) Arm n=9 Participants 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	Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm n=10 Participants 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
Neurotoxicity Assessment at Cycle 2	13.0 units on a scale Standard Deviation 10.9	12.0 units on a scale Standard Deviation 9.9	9.7 units on a scale Standard Deviation 5.99	8.4 units on a scale Standard Deviation 7.16	14.56 units on a scale Standard Deviation 12.9	5.6 units on a scale Standard Deviation 6.59

PRIMARY outcome

Timeframe: 4 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Taxane Group: Multivitamin (MV) Arm n=67 Participants 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	Taxane Group: MV + Vitamin B12 + Vitamin B6 n=58 Participants 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	Heavy Metals Group: Multivitamin (MV) Arm n=28 Participants 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	Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm n=21 Participants 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	Vinca Alkaloids Group: Multivitamin (MV) Arm n=6 Participants 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	Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm n=9 Participants 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
Neurotoxicity Assessment at Cycle 4	14.5 units on a scale Standard Deviation 11.4	14.5 units on a scale Standard Deviation 11.1	8.71 units on a scale Standard Deviation 6.5	7.05 units on a scale Standard Deviation 6.55	17.5 units on a scale Standard Deviation 5.36	9.22 units on a scale Standard Deviation 10.22

PRIMARY outcome

Timeframe: 4 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Taxane Group: Multivitamin (MV) Arm n=54 Participants 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	Taxane Group: MV + Vitamin B12 + Vitamin B6 n=62 Participants 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	Heavy Metals Group: Multivitamin (MV) Arm n=28 Participants 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	Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm n=20 Participants 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	Vinca Alkaloids Group: Multivitamin (MV) Arm n=5 Participants 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	Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm n=9 Participants 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
Change in Neurotoxicity Assessment Between Cycle 4 and Baseline	7.0 units on a scale Standard Deviation 9.9	7.2 units on a scale Standard Deviation 9.8	3.9 units on a scale Standard Deviation 7.1	4.7 units on a scale Standard Deviation 5.7	11.8 units on a scale Standard Deviation 4.7	7 units on a scale Standard Deviation 9.2

Adverse Events

Multivitamin (MV)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multivitamin + Vitamin B12 + Vitamin B6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zoneddy Dayao, MD

University of New Mexico

Phone: 5059250404

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place