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Sponsor: University of California, San Francisco
Conditions: Breast Cancer, Chemotherapeutic Agent Toxicity, Palmar-plantar Erythrodysesthesia
Interventions: Nicotine patch
Countries: United States
RATIONALE: Nicotine patches may reduce hand-foot syndrome in patients receiving capecitabine for metastatic breast cancer. It is not yet known which nicotine patch regimen may be more effective in reducing hand-foot syndrome. PURPOSE: This randomized clinical trial is studying which schedule of using nicotine patches is more effective in reducing hand-foot syndrome in patients who are receiving capecitabine for metastatic breast cancer.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Metastatic disease * Scheduled to begin treatment with capecitabine at the University of California, San Francisco (UCSF) Cancer Center, San Francisco General Hospital, or Cornell Medical Center * No concurrent hand-foot syndrome (HFS) due to other medications * Prior HFS due to other medications allowed provided that the symptoms have been completely resolved for ≥ 4 weeks prior to study entry * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study therapy * Able to participate in study procedures and quality-of-life evaluations and willing to comply with study requirements * Non-English speaking patients are allowed provided they demonstrate adequate understanding of the study rationale and procedures and can give voluntary consent with the aid of a translator * No clinically significant cardiac or peripheral vascular disease or symptom, including any of the following: * History of myocardial infarction * Congestive heart failure * Cardiac arrhythmias (including atrial fibrillation) * Cardiac or vascular bypass * Uncontrolled hypertension * Unstable angina * Undiagnosed arrhythmias or claudication * No Alzheimer disease, Parkinson disease, or active psychiatric disease * Not currently smoking * Patients who are former smokers must have stopped smoking ≥ 6 months prior to study entry * No known hypersensitivity to nicotine patches PRIOR CONCURRENT THERAPY: * At least 6 months since prior and no other concurrent nicotine patches * Prior chemotherapy allowed, except capecitabine for treatment of metastatic disease * Concurrent other symptomatic treatment for hand-foot syndrome (HFS) (e.g., usual skin care, topical moisturizers, ice packs, pain medications) allowed * No concurrent pyridoxine
- San Francisco, California, United States