Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Me… (NCT00751101) | Clinical Trial Compass
TerminatedPhase 2
Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer
Stopped: Low Accrual
United States24 participantsStarted 2007-08-20
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 disea…
What they're measuring
1
Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade