Breast Cancer Clinical Trial
Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer
Summary
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.
Full Description
OBJECTIVES:
Primary
Determine the feasibility of using nicotine patches, in terms of side effects and the number of voluntary withdrawals from the study, in patients with metastatic breast cancer undergoing chemotherapy with capecitabine.
Secondary
Determine the efficacy of nicotine patches as preventive agents for hand-foot syndrome (HFS) by assessing the incidence of HFS in each arm.
Determine the grade of HFS in each arm.
Determine the percentage of patients requiring a reduction in dose of capecitabine due to adverse events.
Determine the percentage of patients requiring pain medication for HFS.
Determine the percentage of patients using other symptomatic treatments for HFS (e.g., moisturizers, ice, cooling packs).
Evaluate the effect of nicotine patches on quality-of-life of patients undergoing capecitabine chemotherapy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients receive oral capecitabine twice daily on days 1-7 and 15-21. Treatment with capecitabine repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Arm I: Patients apply a transdermal nicotine patch once every 24 hours beginning on 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
Arm II: Patients apply a transdermal nicotine patch once every 24 hours beginning on day 1 of the course of chemotherapy following the appearance of hand-foot syndrome symptoms. Treatment continues until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, and at 3 and 12 weeks. Patients also complete a daily diary to document side effects and medication compliance.
After completion of study therapy, patients are followed at 3 weeks.
Eligibility Criteria
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
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There is 1 Location for this study
San Francisco California, 94115, United States
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