Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-21

Study Completion Date

2010-03-17

Brief Summary

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Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.

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Detailed Description

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Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.

Conditions

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Hand and Foot Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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vitamin B6

patient receiving xeloda and vitamin B6

Group Type EXPERIMENTAL

Vitamin B 6

Intervention Type DRUG

vitamin b6 100 mg po daily

2 placebo

patient receiving xeloda and placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo is given in the placebo arm

Interventions

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Vitamin B 6

vitamin b6 100 mg po daily

Intervention Type DRUG

placebo

placebo is given in the placebo arm

Intervention Type DRUG

Other Intervention Names

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pyridoxine

Eligibility Criteria

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Inclusion Criteria

* Any adult patient starting capecitabine-containing chemotherapy
* Has never had capecitabine before
* Performance status 0-2 using the ECOG classification
* Life expectancy more than 6 months
* Agreed to stop any vitamin supplements, apart from vitamin D.
* Liver function studies including AST/ALT within 3x upper limit of normal
* Signed informed consent must be obtained from participating individuals

Eligible Sex

ALL

Accepts Healthy Volunteers

No