Dermatologic Complications, Palmar-plantar Erythrodysesthesia, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
dermatologic complications, chemotherapeutic agent toxicity, palmar-plantar erythrodysesthesia, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer. PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTpyridoxine hydrochloride
Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle
OTHERPlacebo
Sponsors
National Cancer Centre, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0 | up to 8 cycles |
Secondary
| Measure | Time frame |
|---|---|
| Time to the onset of HFS ≥ grade 2 | days to weeks |
| Quality of life as measured by EuroQOL (EQ-5D) questionnaire | QOL assessment at baseline, at beginning of cycles 2, 4, 6, 8 and at the end of the study. |
Countries
Singapore
Outcome results
None listed