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

Primary Purpose

Breast Cancer, Colorectal Cancer, Palmar-plantar Erythrodysesthesia

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
pyridoxine hydrochloride
placebo
quality-of-life assessment
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring palmar-plantar erythrodysesthesia, breast cancer, male breast cancer, colon cancer, rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Basildon University Hospital
  • Primrose Oncology Unit
  • West Suffolk Hospital
  • Addenbrooke's Hospital
  • Kent and Canterbury Hospital
  • Derbyshire Royal Infirmary
  • Royal Devon and Exeter Hospital
  • Queen Elizabeth Hospital
  • Royal Albert Edward Infirmary
  • Mid Kent Oncology Centre at Maidstone Hospital
  • Peterborough Hospitals Trust
  • Derriford Hospital
  • Great Western Hospital
  • Kent and Sussex Hospital
  • Walsall Manor Hospital
  • Southend University Hospital NHS Foundation Trust

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of hand-foot syndrome (HFS)
Overall toxicity
Quality of life
Response to chemotherapy
Progression-free survival
Measurement of biomarkers that might predict the occurrence of HFS

Full Information

First Posted
November 15, 2007
Last Updated
August 1, 2013
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00559858
Brief Title
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
Official Title
A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Palmar-plantar Erythrodysesthesia
Keywords
palmar-plantar erythrodysesthesia, breast cancer, male breast cancer, colon cancer, rectal cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
pyridoxine hydrochloride
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
Secondary Outcome Measure Information:
Title
Incidence of hand-foot syndrome (HFS)
Title
Overall toxicity
Title
Quality of life
Title
Response to chemotherapy
Title
Progression-free survival
Title
Measurement of biomarkers that might predict the occurrence of HFS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pippa Corrie, PhD, FRCP
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Basildon University Hospital
City
Basildon
State/Province
England
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Primrose Oncology Unit
City
Bedford
State/Province
England
ZIP/Postal Code
MK42 9DJ
Country
United Kingdom
Facility Name
West Suffolk Hospital
City
Bury St. Edmunds
State/Province
England
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
England
ZIP/Postal Code
CT2 7NR
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
State/Province
England
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Royal Albert Edward Infirmary
City
Lancanshire
State/Province
England
ZIP/Postal Code
WN1 2NN
Country
United Kingdom
Facility Name
Mid Kent Oncology Centre at Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Peterborough Hospitals Trust
City
Peterborough
State/Province
England
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
State/Province
England
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Kent and Sussex Hospital
City
Tunbridge Wells
State/Province
England
ZIP/Postal Code
TN4 8AT
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
England
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom

12. IPD Sharing Statement

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

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