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

Hand and Foot Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00767689
• Other study ID #: 08-069
• Status: Terminated
• Phase: N/A
• Start date: March 21, 2006
• Est. completion date: March 17, 2010

Study information

• Verified date: June 2023
• Source: Cook County Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 17, 2010
• Est. primary completion date: March 18, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hand and Foot Syndrome
• Hand-Foot Syndrome
• Syndrome

Intervention

Drug:
• Vitamin B 6
vitamin b6 100 mg po daily
• placebo
placebo is given in the placebo arm

Locations

Country	Name	City	State
United States	John H stroger Jr hospital of cook county	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cook County Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hand-Foot Syndrome (HFS)	Incidence of HFS based on CTCTAE adverse event table	1 year
Secondary	Grade of Hand-Foot Syndrome (HFS)	Grading of HFS: Grade 1, Grade 2, Grade 3 per NCI CTCTAE V 3	1 year