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 |
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Recruitment Status
:
Completed
First Posted
: April 16, 2008
Results First Posted
: January 25, 2016
Last Update Posted
: February 26, 2016
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Sponsor:
New Mexico Cancer Care Alliance
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Dietary Supplement: Multivitamin (MV) Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6 Drug: Chemotherapy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 319 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients. |
| Study Start Date : | July 2006 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | June 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
B Vitamins
Drug Information available for:
Pyridoxine hydrochloride
Pyridoxine
Cyanocobalamin
Vitamin B Complex
Cobalamin
Hydroxocobalamin
Infuvite Adult
Infuvite Pediatric
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Multivitamin (MV)
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)
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Dietary Supplement: 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.
Drug: Chemotherapy
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 Other Names:
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Experimental: Multivitamin + Vitamin B12 + Vitamin B6
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:
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Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6
Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections
Drug: Chemotherapy
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 Other Names:
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Primary Outcome Measures
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- Neurotoxicity Assessment at Baseline [ Time Frame: At study start; prior to treatment (week 0) ]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 Assessment at Cycle 2 [ Time Frame: 2 weeks ]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 Assessment at Cycle 4 [ Time Frame: 4 weeks ]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.
- Change in Neurotoxicity Assessment Between Cycle 4 and Baseline [ Time Frame: 4 weeks ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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All patients, 18 years of age or older, with a cancer treated with any of the following drugs are eligible:
- Taxanes, vinca alkaloid analogs, heavy metals.
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Each patient will be allocated to the following 3 groups:
- Group 1 (Heavy metals): Patients treated with cisplatin (>25 mg/m2/week dose intensity) or oxaliplatin
- Group 2 (Taxane): Patients treated with paclitaxel, docetaxel or abraxane
- Group 3 (Vinca alkaloids): Patients treated with vincristine and vinorelbine.
- Patients must have a life expectancy of at least 24 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.
Exclusion Criteria:
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent complementary medicines during this study.
- Patients with neuropathy induced diabetes are not eligible for this study
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659269
Locations
| United States, New Mexico | |
| University of New Mexico Cancer Center @ Lovelace Medical Center | |
| Albuquerque, New Mexico, United States, 87102 | |
| Hematology Oncology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| Cancer Center at Presbyterian Hospital | |
| Albuquerque, New Mexico, United States, 87110 | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| New Mexico Cancer Care Associates | |
| Santa Fe, New Mexico, United States, 87505 | |
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
| Principal Investigator: | Zoneddy Dayao, MD | UNM Cancer Center |
Additional Information:
| 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 Posted: | April 16, 2008 Key Record Dates |
| Results First Posted: | January 25, 2016 |
| Last Update Posted: | February 26, 2016 |
| Last Verified: | January 2016 |
Keywords provided by New Mexico Cancer Care Alliance:
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Vitamin B-12 Vitamin B-6 Chemotherapy-Induced Neuropathy Taxanes |
Vinca alkaloid Heavy metals Neuropathy Nerve pain |
Additional relevant MeSH terms:
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Vitamins Hydroxocobalamin Vitamin B 12 Vitamin B 6 Pyridoxal Pyridoxine Paclitaxel Vincristine Vinorelbine Docetaxel Vinca Alkaloids Oxaliplatin Cisplatin |
Albumin-Bound Paclitaxel Vitamin B Complex Micronutrients Growth Substances Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Hematinics |