Phase 3
N=319
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00659269 ↗Enrolled (actual)
319
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Neurotoxicity Assessment at Baseline — 8.5; 7.3; 5.23; 4.58 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Multivitamin (MV) (Dietary_supplement); Multivitamin + Vitamin B12 + Vitamin B6 (Dietary_supplement); Chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New Mexico Cancer Research Alliance
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurotoxicity Assessment at Baseline |
8.5; 7.3; 5.23; 4.58; 6.80; 2.08 | — |
| PRIMARY Neurotoxicity Assessment at Cycle 2 |
13.0; 12.0; 9.7; 8.4; 14.56; 5.6 | — |
| PRIMARY Neurotoxicity Assessment at Cycle 4 |
14.5; 14.5; 8.71; 7.05; 17.5; 9.22 | — |
| PRIMARY Change in Neurotoxicity Assessment Between Cycle 4 and Baseline |
7.0; 7.2; 3.9; 4.7; 11.8; 7 | 0.91 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00659269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.