Symptoms and General Pathology

All Conditions

Pain

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Vinorelbine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Vincristine

Cisplatin

Oxaliplatin

Vitamin B 6

Pyridoxal

Pyridoxine

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Taxane

Vinca Alkaloids

Folic Acid

Tubulin Modulators

Antimitotic Agents

Trace Elements

Vitamin B6

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

Folate

Vitamin B9

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)

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).

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.

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.

Multivitamin (MV)

Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6

Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine)

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

paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800

Chemotherapy

Zoneddy Dayao, MD

Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy.

Neuropathy can be a significant side effect of chemotherapy using platinum compounds, taxanes, and vinca alkaloids. There is clinical and preclinical data that vitamin B6 and B12 may alleviate neuropathy in experimentally induced neuropathy in animal models, or clinical neuropathy such as diabetic neuropathy. This is a randomized phase III study of the use of multivitamins with or without vitamin B6 and B12 to prevent or relieve neuropathic toxicity from chemotherapy in patients receiving chemotherapy. Patients will be stratified by type of chemotherapy agent (3 groups), presence or absence of neuropathy at baseline, and randomized to receive placebo or vitamin B6/B12 supplementation.

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

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

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.

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.

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.

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.

New Mexico Cancer Care Alliance

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.

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

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

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.

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: Multivitamin (MV) Arm

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

Taxane Group: MV + Vitamin B12 + Vitamin B6

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: Multivitamin (MV) Arm

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

Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm

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: Multivitamin (MV) Arm

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

Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm

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 Assessment at Baseline

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 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

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 Assessment at Cycle 2

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

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 Assessment at Cycle 4

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

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)

Spots Global Cancer Trial Database for A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients

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