Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer
Condition: Breast Cancer; Chemotherapeutic Agent Toxicity; Palmar-plantar Erythrodysesthesia
MeSH terms: Breast Neoplasms; Hand-Foot Syndrome
Intervention: Nicotine patch
Intervention description: Nicotine patch applied prior to and concurrently with capecitabine chemotherapy or beginning during the first course of capecitabine after the onset of hand-foot syndrome symptoms
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: palmar-plantar erythrodysesthesia; chemotherapeutic agent toxicity; stage IV breast cancer; recurrent 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.
    

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