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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00751101
Recruitment Status : Terminated (Low Accrual)
First Posted : September 11, 2008
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Chemotherapeutic Agent Toxicity Palmar-plantar Erythrodysesthesia Drug: Nicotine patch Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : August 20, 2007
Actual Primary Completion Date : March 24, 2014
Actual Study Completion Date : March 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Prior to initiation of capecitabine
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 patch
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 B: After hand-foot syndrome symptoms appear
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 patch
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




Primary Outcome Measures :
  1. Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade [ Time Frame: up to 24 weeks ]
    Incidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 for all patients assigned who received at least 1 cycle of capecitabine.


Secondary Outcome Measures :
  1. Frequency of Side Effects of the Transdermal Nicotine Patch [ Time Frame: Up to 15 weeks ]
    Beginning from first capecitabine cycle following first use of nicotine patch up through final study visit after approximately 15 weeks of nicotine patch use. All toxicities will be graded and classified according to NCI CTCAE version 3.0.

  2. Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary [ Time Frame: up to 15 weeks ]
    Self-report diaries of patch use beginning from capecitabine cycle following first use of nicotine patch use up through 15 weeks of possible nicotine patch use. Compliance will be reported by category (Compliant, Not Compliant, No Diaries Returned)

  3. Number of Patients Requiring Dose Reduction of Capecitabine [ Time Frame: up to 24 weeks ]
    Determined by the number of patients who required a toxicity-related, dose reduction of capecitabine during active treatment at each cycle where a dose reduction occurred.

  4. Number of Patients With Reported Use of Pain Medication for HFS [ Time Frame: Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year ]
    Determine the number of patients requiring pain medication for the management of symptomatic HFS

  5. Number of Patients With Reported Use of Other Symptomatic Treatments for HFS [ Time Frame: Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year ]
    Determine the number of patients utilizing additional treatments for symptomatic HFS. Additional treatments may include moisturizers, ice, and/or cooling packs

  6. Quality of Life as Measured by FACT-B Scale [ Time Frame: Up to 15 weeks ]
    The Functional Assessment of Cancer Therapy - Breast (FACT-B) scale is widely used to measure health-related quality of life in cancer patients. The FACT-B is a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer, given at screening, week 9, and week 15 assessments during nicotine patch use.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751101


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Hoffmann-La Roche
Investigators
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Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00751101    
Other Study ID Numbers: 057514
ROCHE-UCSF-057514 ( Other Identifier: University of California, San Francisco )
NCI-2011-03236 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: September 11, 2008    Key Record Dates
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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:
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Breast Neoplasms
Hand-Foot Syndrome
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Drug Eruptions
Dermatitis
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action