Who is sponsoring NCT00659269?

NCT00659269 is sponsored by New Mexico Cancer Research Alliance.

What drugs are being tested in NCT00659269?

Interventions: Multivitamin (MV), Multivitamin + Vitamin B12 + Vitamin B6, Chemotherapy.

What is the status of NCT00659269?

NCT00659269 is currently COMPLETED.

Last reviewed 2016-01-27 · How we verify

A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.

NCT00659269 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	New Mexico Cancer Research Alliance
Phase	Phase 3
Status	COMPLETED
Enrolment	319
Start date	2006-07
Completion	2015-06

Conditions

Cancer

Interventions

Multivitamin (MV)
Multivitamin + Vitamin B12 + Vitamin B6
Chemotherapy

Primary outcomes

Neurotoxicity Assessment at Baseline — 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 — 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 — 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 — 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.

Countries

United States