Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00559858
• Other study ID #: CRCA-CCTC-CAPP-IT
• Secondary ID: CDR0000576453EUD
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 15, 2007
• Last updated: August 1, 2013
• Start date: December 2004

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome.

PURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving capecitabine for advanced colorectal cancer or breast cancer.

Description:

OBJECTIVES:

Primary

• Determine whether pyridoxine can reduce the incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.

Secondary

• Determine the incidence of hand-foot syndrome (HFS).

• Determine the overall toxicity.

• Determine the quality of life.

• Determine the response to chemotherapy.

• Determine the progression-free survival.

• Determine the level of biomarkers which might predict the occurrence of HFS.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (breast cancer vs colorectal cancer). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral pyridoxine hydrochloride 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy.

• Arm II: Patients receive oral placebo 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Evidence of hand-foot syndrome is assessed at baseline and before each course of capecitabine. Quality of life is assessed at baseline and then every 6 weeks.

After completion of study treatment, patients are followed at 6 and 12 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of advanced colorectal or breast carcinoma

• Hormone receptor status not specified

• Receiving single-agent capecitabine chemotherapy

• Measurable disease for response assessment, determined on an individual patient basis, using conventional clinical and/or radiological methods

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Menopausal status not specified

• Life expectancy = 12 weeks

• Hemoglobin = 10 g/dL

• Platelet count = 100,000 mm^3

• WBC = 3,000/mm^3

• ANC = 1,500/mm^3

• Bilirubin = 1.3 x upper limit of normal (ULN)

• Alkaline phosphatase = 5 x ULN

• AST and ALT = 5 x ULN

• Creatinine = 1.5 x ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• No other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

• No medical or psychiatric condition which would influence the ability to provide informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 6 weeks since prior investigational agents

• Concurrent radiotherapy allowed

• No other concurrent chemotherapy or immunotherapy

• No concurrent nonsteroidal anti-inflammatory drugs NSAIDs) for the primary purpose of treating hand-foot syndrome (HFS) or cancer

• NSAIDs for conditions other than HFS or cancer allowed

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Hand-Foot Syndrome
• Palmar-plantar Erythrodysesthesia

Intervention

Dietary Supplement:
• pyridoxine hydrochloride

Other:
• placebo

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Primrose Oncology Unit	Bedford	England
United Kingdom	West Suffolk Hospital	Bury St. Edmunds	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Queen Elizabeth Hospital	King's Lynn	England
United Kingdom	Royal Albert Edward Infirmary	Lancanshire	England
United Kingdom	Mid Kent Oncology Centre at Maidstone Hospital	Maidstone	England
United Kingdom	Peterborough Hospitals Trust	Peterborough	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Great Western Hospital	Swindon	England
United Kingdom	Kent and Sussex Hospital	Tunbridge Wells	England
United Kingdom	Walsall Manor Hospital	Walsall	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
Secondary	Incidence of hand-foot syndrome (HFS)
Secondary	Overall toxicity
Secondary	Quality of life
Secondary	Response to chemotherapy
Secondary	Progression-free survival
Secondary	Measurement of biomarkers that might predict the occurrence of HFS