Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000161527
Ethics application status
Approved
Date submitted
14/12/2005
Date registered
8/05/2006
Date last updated
8/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised double-blind placebo controlled trial of pyridoxine for prevention of capecitabine induced hand-foot syndrome
Scientific title
Randomised double-blind placebo controlled trial of pyridoxine for prevention of capecitabine induced hand-foot syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Capecitabine induced hand-foot syndrome (HFS) 1134 0
Condition category
Condition code
Blood 1213 1213 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The specific pathophysiologic mechanism of HFS is unclear. The clinical features of HFS are characteristic and evolve in stages. Most patients have their first (92.9%) or most severe (67.9%) episode of HFS within the first two cycles of treatment.11

Initially, symptoms are very mild with no obvious changes to the hands and feet. Patients may experience a prodrome of about 3 to 5 days, which consists of vague paraesthesias and tingling of the extremities, or painless swelling or erythema (grade 1). If the drug is continued, the syndrome progresses with painful erythema and swelling (grade 2). It may further progress to fissuring, ulceration and desquamation involving the hands and feet, leading to extreme pain when grasping objects or walking (grade 3).11 Resolution of HFS occurs upon discontinuation of capecitabine. Histologically, the condition is marked by hyperkeratosis associated with an inflammatory cell infiltrate and an increase in vascularity of the dermis. The treatment group will receive oral Pyridoxine 200gm daily for 24 weeks.
Intervention code [1] 802 0
Prevention
Comparator / control treatment
The control group will receive oral placebo for 24 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 1644 0
Incidence of Grade 2 or greater Hand Foot Syndrome (HFS)
Timepoint [1] 1644 0
Assessed clinically every three weeks, and via phone contact weekly
Primary outcome [2] 1645 0
Severity is graded according to Commom Toxicity Criteria for Adverese Events (CTCAE) Version 3
Timepoint [2] 1645 0
Assessed clinically every three weeks, and via phone contact weekly
Secondary outcome [1] 2941 0
Time to onset of grade 2 or higher HFS will be evaluated in days.
Timepoint [1] 2941 0
The duration of treatment is 24 weeks.
Assessment for the primary end-point will occur at clinic visitsand via weekly phone calls from the research nurse.

Eligibility
Key inclusion criteria
Commencement of capecitabine at a dose of 800mg/m2 BD every 2 out of 3 weeks either as single agent or combination therapySigned informed consent. Life expectancy greater than 12 weeksConcommitant radiotherapy or steroids permitted
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior capecitabine chemotherapy over the past 30 daysInability to provide informed consentConcommitant administration of drugs that cause HFS eg docetaxel, liposomal doxorubicinConsumption of pyridoxine-containing preparationsAnticipated inability to follow up patient for side effects of chemotherapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computerised randomisation package with sealed opaque envelopes made up by non research team individual
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
288
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1325 0
Hospital
Name [1] 1325 0
Flinders Medical Centre
Country [1] 1325 0
Australia
Primary sponsor type
Individual
Name
Dr Chris Karapetis
Address
Country
Secondary sponsor category [1] 1170 0
None
Name [1] 1170 0
Nil
Address [1] 1170 0
Country [1] 1170 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2649 0
Flinders Medical Centre
Ethics committee address [1] 2649 0
Ethics committee country [1] 2649 0
Australia
Date submitted for ethics approval [1] 2649 0
Approval date [1] 2649 0
22/02/2005
Ethics approval number [1] 2649 0
89/045

Summary
Brief summary
Capecitabine (Xeloda) is an oral chemotherapy agent that has shown to be effective in breast and gastrointestinal cancers. Patients receiving Xeloda tend to experience less severe side effects such as diarrhoea, mouth sores, nausea , hair loss and reduced white blood counts. Hand and foot syndrome (HFS) is a common complication for patients receiving Xeloda. Although it is not a life-threatening complication, it can be disabling in severe cases and affects the treatment course due to the need for dose interuption or reducation. Some previous research has suggested that the addition of Pydidoxine (vitamin B) to the chemotherapy may reduce the incidence and severity of HFS. The study is a double blind study comparing the administration of oral 200mg pryidoxine with an oral placebo for 24 weeks. Neither the patient of the Doctor will know what treatment (active drug or placebo) the patient will be allocated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36182 0
Address 36182 0
Country 36182 0
Phone 36182 0
Fax 36182 0
Email 36182 0
Contact person for public queries
Name 9991 0
Ms Alison Richards
Address 9991 0
Department of Medical Oncology
Flinders Medical Centre
Bedford Park SA 5042
Country 9991 0
Australia
Phone 9991 0
+61 8 82048997
Fax 9991 0
+61 8 82044997
Email 9991 0
alison.richards @fmc.sa.gov.au
Contact person for scientific queries
Name 919 0
Dr Chris Karapetis
Address 919 0
Clinical Trials Unit
Department of Medical Oncology
Flinders Medical Centre
Bedford Park SA 5042
Country 919 0
Australia
Phone 919 0
+61 8 82048997
Fax 919 0
+61 8 82044997
Email 919 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.