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

NCT00559858 | Unknown Phase 3

• 6 other identifiers: CRCA-CCTC-CAPP-ITCDR0000576453EUDRACT-2004-000325-29EU-20786ISRCTN82842634CCLG-CAPP-IT
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Breast Cancer; Colorectal Cancer; Palmar-plantar Erythrodysesthesia

Keywords

palmar-plantar erythrodysesthesia; breast cancer; male breast cancer; colon cancer; rectal cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity

Secondary Outcomes (6)

• Incidence of hand-foot syndrome (HFS)

• Overall toxicity

• Quality of life

• Response to chemotherapy

• Progression-free survival

Interventions

pyridoxine hydrochloride DIETARY_SUPPLEMENT

placebo OTHER

quality-of-life assessment PROCEDURE

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (16)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Primrose Oncology Unit

Bedford, England, MK42 9DJ, United Kingdom

Location

West Suffolk Hospital

Bury St Edmunds, England, IP33 2QZ, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, England, PE30 4ET, United Kingdom

Location

Royal Albert Edward Infirmary

Lancanshire, England, WN1 2NN, United Kingdom

Location

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Kent and Sussex Hospital

Royal Tunbridge Wells, England, TN4 8AT, United Kingdom

Location

Great Western Hospital

Swindon, England, SN3 6BB, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Hand-Foot Syndrome; Breast Neoplasms, Male; Colonic Neoplasms; Rectal Neoplasms

Interventions

Pyridoxine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Drug Eruptions; Dermatitis; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pippa Corrie, PhD, FRCP

  Cambridge University Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2004
• Primary Completion: December 1, 2009
• Last Updated: August 2, 2013

Record last verified: 2008-12

Locations

GB (16)