Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00559858
First received: November 15, 2007
Last updated: October 30, 2010
Last verified: December 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Colorectal Cancer Palmar-Plantar Erythrodysesthesia |
Dietary Supplement: pyridoxine hydrochloride Other: placebo Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
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
| Estimated Enrollment: | 270 |
| Study Start Date: | December 2004 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559858
Locations
| United Kingdom | |
| Basildon University Hospital | |
| Basildon, England, United Kingdom, SS16 5NL | |
| Primrose Oncology Unit | |
| Bedford, England, United Kingdom, MK42 9DJ | |
| West Suffolk Hospital | |
| Bury St. Edmunds, England, United Kingdom, IP33 2QZ | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Kent and Canterbury Hospital | |
| Canterbury, England, United Kingdom, CT2 7NR | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Royal Devon and Exeter Hospital | |
| Exeter, England, United Kingdom, EX2 5DW | |
| Queen Elizabeth Hospital | |
| King's Lynn, England, United Kingdom, PE30 4ET | |
| Royal Albert Edward Infirmary | |
| Lancanshire, England, United Kingdom, WN1 2NN | |
| Mid Kent Oncology Centre at Maidstone Hospital | |
| Maidstone, England, United Kingdom, ME16 9QQ | |
| Peterborough Hospitals Trust | |
| Peterborough, England, United Kingdom, PE3 6DA | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Great Western Hospital | |
| Swindon, England, United Kingdom, SN3 6BB | |
| Kent and Sussex Hospital | |
| Tunbridge Wells, England, United Kingdom, TN4 8AT | |
| Walsall Manor Hospital | |
| Walsall, England, United Kingdom, WS2 9PS | |
| Southend University Hospital NHS Foundation Trust | |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
| Study Chair: | Pippa Corrie, PhD, FRCP | Cambridge University Hospitals NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00559858 History of Changes |
| Other Study ID Numbers: | CDR0000576453, CRCA-CCTC-CAPP-IT, EUDRACT-2004-000325-29, EU-20786, ISRCTN82842634, CCLG-CAPP-IT |
| Study First Received: | November 15, 2007 |
| Last Updated: | October 30, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
palmar-plantar erythrodysesthesia breast cancer male breast cancer colon cancer rectal cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Colorectal Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Pyridoxine |
Vitamin B 6 Pyridoxal Capecitabine Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013