ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

21/07/2024

Date data sharing statement initially provided

21/07/2024

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)

Condition category

Condition code

Blood

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]

Prevention

Comparator / control treatment

The control group will receive oral placebo for 24 weeks.

Control group

Placebo

Outcomes

Primary outcome [1]

Incidence of Grade 2 or greater Hand Foot Syndrome (HFS)

Timepoint [1]

Assessed clinically every three weeks, and via phone contact weekly

Primary outcome [2]

Severity is graded according to Commom Toxicity Criteria for Adverese Events (CTCAE) Version 3

Timepoint [2]

Assessed clinically every three weeks, and via phone contact weekly

Secondary outcome [1]

Time to onset of grade 2 or higher HFS will be evaluated in days.

Timepoint [1]

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?

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

Withdrawn

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

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]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Chris Karapetis

Address

Country

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders Medical Centre

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/02/2005

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms Alison Richards

Address

Department of Medical Oncology
Flinders Medical Centre
Bedford Park SA 5042

Country

Australia

Phone

+61 8 82048997

Fax

+61 8 82044997

alison.richards @fmc.sa.gov.au

Contact person for scientific queries

Name

Dr Chris Karapetis

Address

Clinical Trials Unit
Department of Medical Oncology
Flinders Medical Centre
Bedford Park SA 5042

Country

Australia

Phone

+61 8 82048997

Fax

+61 8 82044997

chris.karapetis@fmc.sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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.

Trial Review

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