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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00751101
First received: September 10, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Chemotherapeutic Agent Toxicity
Palmar-plantar Erythrodysesthesia
Drug: nicotine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome Associated With Capecitabine Chemotherapy in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Incidence and severity of hand-foot syndrome (HFS) as measured by NCI CTCAE v3.0 [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Side effects of the transdermal nicotine patch as measured by NCI CTCAE v3.0 [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    screening, week 9, and week 15


Enrollment: 24
Study Start Date: August 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients apply a transdermal nicotine patch once every 24 hours beginning 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
Drug: nicotine
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
Experimental: Arm II
Patients apply a transdermal nicotine patch once every 24 hours beginning with the course of chemotherapy initiated after hand-foot syndrome symptoms appear and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.
Drug: nicotine
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Metastatic disease
  • Scheduled to begin treatment with capecitabine at the 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751101

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00751101     History of Changes
Other Study ID Numbers: CDR0000613046, UCSF-057514, ROCHE-UCSF-057514
Study First Received: September 10, 2008
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
palmar-plantar erythrodysesthesia
chemotherapeutic agent toxicity
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Nicotine
Nicotine polacrilex
Capecitabine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014