Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2018-03-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Hoffmann-La Roche; National Cancer Institute (NCI)
• Treatments: Capecitabine; Nicotine

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