Breast CancerPhase 3NCT00559858
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
A Phase 3 study testing pyridoxine hydrochloride and quality-of-life assessment in people with Breast Cancer and Colorectal Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 16 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Palmar-plantar Erythrodysesthesia
- What is being tested?
- pyridoxine hydrochloride and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- Dec 2004to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United Kingdom16 sites
Basildon University Hospital
Basildon, England, SS16 5NL
Primrose Oncology Unit
Bedford, England, MK42 9DJ
West Suffolk Hospital
Bury St Edmunds, England, IP33 2QZ
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Kent and Canterbury Hospital
Canterbury, England, CT2 7NR
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Queen Elizabeth Hospital
Kings Lynn, England, PE30 4ET
Royal Albert Edward Infirmary
Lancanshire, England, WN1 2NN
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, ME16 9QQ
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
Derriford Hospital
Plymouth, England, PL6 8DH
Kent and Sussex Hospital
Royal Tunbridge Wells, England, TN4 8AT
Great Western Hospital
Swindon, England, SN3 6BB
Walsall Manor Hospital
Walsall, England, WS2 9PS
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
About this study
Official title: A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
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.
Read the 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.
- Being tested
- pyridoxine hydrochloride, placebo, quality-of-life assessment
- Keywords
- palmar-plantar erythrodysesthesia, breast cancer, male breast cancer, colon cancer, rectal cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Hand-Foot Syndrome, Breast Neoplasms, Male, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyridoxine hydrochlorideDietary supplement
placeboOther
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measurement of biomarkers that might predict the occurrence of HFS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startDec 2004
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Pippa Corrie, PhD, FRCP, Study chair, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559858
- Sponsor's protocol ID
- CRCA-CCTC-CAPP-IT
- Other IDs
- CDR0000576453, EUDRACT-2004-000325-29, EU-20786, ISRCTN82842634, CCLG-CAPP-IT
- Status last verified
- Dec 2008
- First submitted
- 15 Nov 2007
- Last updated
- 2 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
- ClinicalTrials.gov ID
- NCT00559858
- Acronym / sponsor ID
- CRCA-CCTC-CAPP-IT
- Keywords
- palmar-plantar erythrodysesthesia, breast cancer, male breast cancer, colon cancer, rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Dec 2009 (estimated)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pyridoxine hydrochloride | Dietary supplement | – |
| placebo | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pippa Corrie, PhD, FRCP study chair
Cambridge University Hospitals NHS Foundation Trust
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pyridoxine hydrochloride and quality-of-life assessment in people with Breast Cancer and Colorectal Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 16 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.