Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
Verified date | September 2015 |
Source | National Cancer Centre, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Health Sciences Authority |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 210 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Singapore | National Cancer Centre - Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National Cancer Centre, Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First incidence of hand-foot syndrome (HFS) = grade 2 according to NCI CTCAE vs 3.0 | up to 8 cycles | No | |
Secondary | Time to the onset of HFS = grade 2 | days to weeks | No | |
Secondary | 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. | No |
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