Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 22 October 2012
• Main ID: NCT00486213
• Date of registration: 13/06/2007
• Primary sponsor: National Cancer Centre, Singapore
• Public title: Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer
• Scientific title: Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
• Date of first enrolment: June 2007
• Target sample size: 296
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00486213
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Countries of recruitment

Singapore

Contacts

• Name: Yoon-Sim Yap, FRACP, MBBS

• Name: Yoon-Sim Yap, FRACP, MBBS
• Affiliation: National Cancer Centre, Singapore

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Diagnosis of cancer

- Must be receiving single-agent capecitabine either in the adjuvant/neoadjuvant or
palliative setting at a dose of = 1000 mg/m² twice daily on days 1-14 (given in
3-week courses)

PATIENT CHARACTERISTICS:

- Life expectancy > 12 weeks

- No preexisting neuropathy

- No known allergy to pyridoxine hydrochloride and its incipients

- No other dermatologic condition that, in the opinion of the physician, may affect the
hands or feet or may complicate evaluation during study treatment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior capecitabine

- Concurrent radiotherapy, steroids, and/or biological therapy (e.g., trastuzumab
[Herceptin®] or bevacizumab) allowed provided they do not cause hand-foot syndrome
(HFS)

- No other concurrent drugs (e.g., docetaxel or doxorubicin hydrochloride liposome)
that can cause HFS

- No concurrent drugs (e.g., oxaliplatin or taxanes) that can cause neuropathy

- No concurrent pyridoxine hydrochloride-containing preparations (e.g., multivitamins
or vitamin B complex)

- No concurrent over-the-counter products that contain urea or lactic acid

- No concurrent drugs reported to have drug interactions with pyridoxine hydrochloride
(e.g., cycloserine; hydralazine; immunosuppressants; isoniazid; levodopa; estrogen or
estrogen-containing contraceptives; penicillamine; phenobarbitone; phenytoin; or
pyrazinamide)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chemotherapeutic Agent Toxicity

Dermatologic Complications

Palmar-plantar Erythrodysesthesia

Unspecified Adult Solid Tumor, Protocol Specific

Intervention(s)

Dietary Supplement: pyridoxine hydrochloride

Drug: capecitabine

Procedure: complementary or alternative medicine procedure

Primary Outcome(s)

First incidence of hand-foot syndrome (HFS) = grade 2 according to NCI CTCAE vs 3.0 [Time Frame: up to 8 cycles]

Secondary Outcome(s)

Quality of life as measured by EuroQOL (EQ-5D) questionnaire [Time Frame: QOL assessment at baseline, at beginning of cycles 2, 4, 6, 8 and at the end of the study.]

Time to the onset of HFS = grade 2 [Time Frame: days to weeks]

Secondary ID(s)

CDR0000551757

SINGAPORE-06-22-OTH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors