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

NCT00767689 | Terminated

• 1 other identifier: 08-069
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand and Foot Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of Hand-Foot Syndrome (HFS)

  Incidence of HFS based on CTCTAE adverse event table

  1 year

Secondary Outcomes (1)

• Grade of Hand-Foot Syndrome (HFS)

  1 year

Study Arms (2)

vitamin B6

EXPERIMENTAL

patient receiving xeloda and vitamin B6

Drug: Vitamin B 6

2 placebo

PLACEBO COMPARATOR

patient receiving xeloda and placebo

Drug: placebo

Interventions

Vitamin B 6 DRUG

vitamin b6 100 mg po daily

Also known as: pyridoxine

vitamin B6

placebo DRUG

placebo is given in the placebo arm

2 placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Cook County Health: lead

Study Sites (1)

John H stroger Jr hospital of cook county

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

Vitamin B 6; Pyridoxine

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Thomas Lad, MD

  Cook County Health Oncology NCORP

  STUDY DIRECTOR

• Susan McDunn, MD

  Cook County Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dir Clinical Research Office

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: March 21, 2006
• Primary Completion: March 18, 2009
• Study Completion: March 17, 2010
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (1)