Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of California, San Francisco
With
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
