Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
18 Years
N/A
Both
Chemotherapeutic Agent Toxicity, Dermatologic Complications, Palmar-plantar Erythrodysesthesia, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
OBJECTIVES:
Primary
- Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia
(hand-foot syndrome [HFS]) ≥ grade 2 in patients with cancer treated with pyridoxine
hydrochloride vs placebo.
Secondary
- Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
- Compare the quality of life changes in patients treated with these regimens.
- Identify factors predicting toxicity from capecitabine chemotherapy.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative
setting). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning concurrently with planned capecitabine treatment, patients receive
oral pyridoxine hydrochloride once daily on days 1-21.
- Arm II: Beginning concurrently with planned capecitabine treatment, patients receive
oral placebo once daily on days 1-21.
In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of
capecitabine treatment).
Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at
the end of the study.
Inclusion 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)
Type of Study:
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
Outcome Measure:
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0
Outcome Time Frame:
up to 8 cycles
Safety Issue:
No
Principal Investigator
Yoon-Sim Yap, FRACP, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Centre, Singapore
Authority:
Singapore: Health Sciences Authority
Study ID:
CDR0000551757
NCT ID:
NCT00486213
Start Date:
June 2007
Completion Date:
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Dermatologic Complications
- Palmar-Plantar Erythrodysesthesia
- Unspecified Adult Solid Tumor, Protocol Specific
- dermatologic complications
- chemotherapeutic agent toxicity
- palmar-plantar erythrodysesthesia
- unspecified adult solid tumor, protocol specific
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