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NCT00659269 · ClinicalTrials.gov registry record · Phase 3
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
A Phase 3 study, sponsored by New Mexico Cancer Research Alliance.
- Completed
- Registry status
- Phase 3
- Development phase
- 319
- Enrollment target
NCT00659269: Completed Phase 3 study, sponsored by New Mexico Cancer Research Alliance.
NCT00659269 is a Phase 3 study that has completed, run by New Mexico Cancer Research Alliance. The registered enrollment target is 319 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00659269, a Phase 3 study, has completed, sponsored by New Mexico Cancer Research Alliance.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 319 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Chemotherapy
- DIETARY_SUPPLEMENT Multivitamin (MV)
- DIETARY_SUPPLEMENT Multivitamin + Vitamin B12 + Vitamin B6
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2006-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT00659269 record still lists
NCT00659269 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Chemotherapy is the first listed.
NCT00659269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00659269 about?
NCT00659269 is a clinical study titled "A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients". 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...
What is the current status of trial NCT00659269?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2006-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00659269?
The interventions under investigation include: Chemotherapy (DRUG), Multivitamin (MV) (DIETARY_SUPPLEMENT), Multivitamin + Vitamin B12 + Vitamin B6 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00659269?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00659269's enrollment target sits among peer trials
319 1087th of 2000 higher than 914 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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