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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659269
• Other study ID #: INST 0553C
• Secondary ID: NCI-2012-00946
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2008
• Last updated: January 27, 2016
• Start date: July 2006
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: June 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Patients must have a life expectancy of at least 24 weeks.

3. Patients must have a Zubrod performance status of 0-2.

4. Patients must sign an informed consent.

5. Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.

Exclusion Criteria:

1. Patients with symptomatic brain metastases are excluded from this study.

2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.

3. Patients may receive no other concurrent complementary medicines during this study.

4. Patients with neuropathy induced diabetes are not eligible for this study

5. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

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

Drug:
• Chemotherapy
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

Locations

Country	Name	City	State
United States	Cancer Center at Presbyterian Hospital	Albuquerque	New Mexico
United States	Hematology Oncology Associates	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center @ Lovelace Medical Center	Albuquerque	New Mexico
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurotoxicity Assessment at Baseline	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.	At study start; prior to treatment (week 0)	Yes
Primary	Neurotoxicity Assessment at Cycle 2	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.	2 weeks	Yes
Primary	Neurotoxicity Assessment at Cycle 4	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.	4 weeks	Yes
Primary	Change in Neurotoxicity Assessment Between Cycle 4 and Baseline	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.	4 weeks	Yes

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center