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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome Associated With Capecitabine Chemotherapy in Patients With Metastatic Breast Cancer

Brief 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.


Detailed Summary:

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 abs
    Sponsor: University of California, San Francisco

    Current Primary Outcome: Incidence and severity of hand-foot syndrome (HFS) as measured by NCI CTCAE v3.0 [ Time Frame: up to 16 weeks ]

    Beginning at second cycle of capecitabine (week 4 for a 21-day cycle), continuing at each cycle (up to 15 weeks of treatment with nicotine patch) with one follow-up visit (at week 16).


    Original Primary Outcome: Incidence and severity of hand-foot syndrome (HFS) as measured by NCI CTCAE v3.0

    Current Secondary Outcome:

    • Side effects of the transdermal nicotine patch as measured by NCI CTCAE v3.0 [ Time Frame: up to 16 weeks ]
      Beginning from capecitabine cycle following first use of nicotine patch up through follow-up visit at 16 weeks
    • Compliance in using the transdermal nicotine patch as measured by patient diary [ Time Frame: up to 15 weeks ]
      Beginning from capecitabine cycle following first use of nicotine patch up through 15 weeks
    • Percentage of patients requiring dose reduction of capecitabine due to any side effects [ Time Frame: up to 15 weeks ]
      capecitabine dose recorded at each cycle, but % of patients requiring reduction only assessed at conclusion of study (i.e. after all patients have either completed 15 weeks of nicotine patch use or have discontinued study participation)
    • Use of pain medication and other symptomatic treatments for HFS [ Time Frame: up to 16 weeks ]
      Beginning at second cycle of capecitabine (week 4 for a 21-day cycle), continuing at each cycle (up to 15 weeks of treatment with nicotine patch) with one follow-up visit (at week 16).
    • Quality of life as measured by FACT-B scale [ Time Frame: up to 15 weeks ]
      screening, week 9, and week 15


    Original Secondary Outcome:

    • Side effects of the transdermal nicotine patch as measured by NCI CTCAE v3.0
    • Compliance in using the transdermal nicotine patch as measured by patient diary
    • Percentage of patients requiring dose reduction of capecitabine due to any side effects
    • Use of pain medication and other symptomatic treatments for HFS
    • Quality of life as measured by FACT-B scale


    Information By: University of California, San Francisco

    Dates:
    Date Received: September 10, 2008
    Date Started: August 2007
    Date Completion: December 2017
    Last Updated: May 12, 2016
    Last Verified: May 2016