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

A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00767689

Enrollment

Registered

2008-10-07

Start date

2006-03-21

Completion date

2010-03-17

Last updated

2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand and Foot Syndrome

Brief summary

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.

Detailed description

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.

Interventions

DRUGVitamin B 6

vitamin b6 100 mg po daily

DRUGplacebo

placebo is given in the placebo arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Hand-Foot Syndrome (HFS)	1 year	Incidence of HFS based on CTCTAE adverse event table

Secondary

Measure	Time frame	Description
Grade of Hand-Foot Syndrome (HFS)	1 year	Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026