A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsor:
New Mexico Cancer Care Alliance
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00659269
First received: April 14, 2008
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
Primary Objective:To determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Dietary Supplement: Multivitamin Dietary Supplement: Vitamin B12, Vitamin B6 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: 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. |
Resource links provided by NLM:
Drug Information available for:
Pyridoxine hydrochloride
Pyridoxine
Cyanocobalamin
Vitamin B Complex
Hydroxocobalamin
U.S. FDA Resources
Further study details as provided by New Mexico Cancer Care Alliance:
Primary Outcome Measures:
- Improvement of neuropathy scores from baseline to the completion of 2 cycles will be analyzed.The same measurement after 4 cycles also will be analyzed & will be reported. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 450 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: MV alone
Multivitamin only
|
Dietary Supplement: Multivitamin
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.
|
|
Experimental: MV+B6+B12
Multivitamin, plus B6 tablets and B12 injections
|
Dietary Supplement: Vitamin B12, Vitamin B6
On the first day of chemotherapy, start
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659269
Locations
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| Hematology Oncology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| University of New Mexico Cancer Center @ Lovelace Medical Center | |
| Albuquerque, New Mexico, United States, 87102 | |
| Cancer Center at Presbyterian Hospital | |
| Albuquerque, New Mexico, United States, 87110 | |
| 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 |
More Information
No publications provided
| Responsible Party: | New Mexico Cancer Care Alliance |
| ClinicalTrials.gov Identifier: | NCT00659269 History of Changes |
| Other Study ID Numbers: | INST 0553C, NCI-2012-00946 |
| Study First Received: | April 14, 2008 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New Mexico Cancer Care Alliance:
|
Vitamin B-12 Vitamin B-6 Chemotherapy-Induced Neuropathy Taxanes |
Vinca alkaloid Heavy metals Neuropathy Nerve pain |
Additional relevant MeSH terms:
|
Hydroxocobalamin Vitamin B 12 Vitamin B 6 Pyridoxine Pyridoxal Vitamin B Complex Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013