A Phase 3 interventional study of Multivitamin (MV) and Multivitamin + Vitamin B12 + Vitamin B6 in Cancer, sponsored by New Mexico Cancer Research Alliance. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-26.
Sponsored by New Mexico Cancer Research Alliance · Phase 3, Interventional, and Prevention
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.
New Mexico Cancer Research Alliance is the lead sponsor of 70 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients, 18 years of age or older, with a cancer treated with any of the following drugs are eligible:
Each patient will be allocated to the following 3 groups:
Exclusion Criteria:
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)
Dietary Supplement: Multivitamin (MV) · Drug: Chemotherapy
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.
Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6 · Drug: Chemotherapy
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 (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections
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
Also known as: Cisplatin (Platinol, Platinol-AQ), Oxaliplatin (Eloxatin), Paclitaxel (Taxol, Abraxane), Docetaxel (Taxotere), Vincristine (Oncovin), Vinorelbine tartrate (Navelbine)
Neurotoxicity Assessment at Baseline
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)
Neurotoxicity Assessment at Cycle 2
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
Neurotoxicity Assessment at Cycle 4
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
Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
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
Subjects were recruited between July, 2006, and September, 2013, at participating cancer clinics across the state of New Mexico
| Milestone | 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 |
| Withdrew: Physician decision | 1 | 1 |
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.
| units on a scale | 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 |
|---|---|---|---|---|---|---|
| Neurotoxicity Assessment at Baseline | 8.5 ± 8.5 | 7.3 ± 7.3 | 5.23 ± 5.86 | 4.58 ± 5.34 | 6.80 ± 5.09 | 2.08 ± 2.02 |
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.
| units on a scale | 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 |
|---|---|---|---|---|---|---|
| Neurotoxicity Assessment at Cycle 2 | 13.0 ± 10.9 | 12.0 ± 9.9 | 9.7 ± 5.99 | 8.4 ± 7.16 | 14.56 ± 12.9 | 5.6 ± 6.59 |
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.
| units on a scale | 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 |
|---|---|---|---|---|---|---|
| Neurotoxicity Assessment at Cycle 4 | 14.5 ± 11.4 | 14.5 ± 11.1 | 8.71 ± 6.5 | 7.05 ± 6.55 | 17.5 ± 5.36 | 9.22 ± 10.22 |
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.
| units on a scale | 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 |
|---|---|---|---|---|---|---|
| Change in Neurotoxicity Assessment Between Cycle 4 and Baseline | 7.0 ± 9.9 | 7.2 ± 9.8 | 3.9 ± 7.1 | 4.7 ± 5.7 | 11.8 ± 4.7 | 7 ± 9.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multivitamin (MV) | — | 0/157 (0%) | — |
| Multivitamin + Vitamin B12 + Vitamin B6 | — | 0/162 (0%) | — |
| Age, Continuous(years) | Multivitamin (MV) | Multivitamin + Vitamin B12 + Vitamin B6 | Total |
|---|---|---|---|
| Median | 56 (23 to 83) | 54.5 (18 to 80) | 55 (18 to 83) |
| Sex: Female, Male(Participants) | Multivitamin (MV) | Multivitamin + Vitamin B12 + Vitamin B6 | Total |
|---|---|---|---|
| Female | 114 | 116 | 230 |
| Male | 43 | 46 | 89 |
| Region of Enrollment(participants) | Multivitamin (MV) | Multivitamin + Vitamin B12 + Vitamin B6 | Total |
|---|---|---|---|
| United States | 157 | 162 | 319 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New Mexico Cancer Research Alliance