Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome Associated With Capecitabine Chemotherapy in Patients With Metastatic Breast Cancer
- 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.
- 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
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.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Incidence and severity of hand-foot syndrome (HFS) as measured by NCI CTCAE v3.0
Hope S. Rugo, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|