CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 319 enrolled
Drug / intervention
Chemotherapy +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00659269
NCT00659269Phase 3Completed
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A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.

New Mexico Cancer Research Alliance·interventional·Posted Apr 16, 2008·Updated Feb 26, 2016

In Brief

A Phase 3 clinical trial evaluating Multivitamin (MV), Multivitamin + Vitamin B12 + Vitamin B6, and 1 other intervention for Cancer. Completed, enrolled 319 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 16, 2008
Enrollment StartJul 1, 2006
Primary CompletionJun 1, 2013
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 18.2 years ago

Interventions

Multivitamin (MV)dietary

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 + Vitamin B12 + Vitamin B6dietary

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

Chemotherapydrug

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