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

Primary Purpose

Breast Cancer, Chemotherapeutic Agent Toxicity, Palmar-plantar Erythrodysesthesia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nicotine patch
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring palmar-plantar erythrodysesthesia, chemotherapeutic agent toxicity, stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: Prior to initiation of capecitabine

Arm B: After hand-foot syndrome symptoms appear

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade
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

Frequency of Side Effects of the Transdermal Nicotine Patch
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.
Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary
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)
Number of Patients Requiring Dose Reduction of Capecitabine
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.
Number of Patients With Reported Use of Pain Medication for HFS
Determine the number of patients requiring pain medication for the management of symptomatic HFS
Number of Patients With Reported Use of Other Symptomatic Treatments for HFS
Determine the number of patients utilizing additional treatments for symptomatic HFS. Additional treatments may include moisturizers, ice, and/or cooling packs
Quality of Life as Measured by FACT-B Scale
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.

Full Information

First Posted
September 10, 2008
Last Updated
September 11, 2020
Sponsor
University of California, San Francisco
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00751101
Brief Title
Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer
Official Title
Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome Associated With Capecitabine Chemotherapy in Patients With Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Low Accrual
Study Start Date
August 20, 2007 (Actual)
Primary Completion Date
March 24, 2014 (Actual)
Study Completion Date
March 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Hoffmann-La Roche

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapeutic Agent Toxicity, Palmar-plantar Erythrodysesthesia
Keywords
palmar-plantar erythrodysesthesia, chemotherapeutic agent toxicity, stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Prior to initiation of capecitabine
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B: After hand-foot syndrome symptoms appear
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
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 Measure Information:
Title
Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade
Description
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.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Frequency of Side Effects of the Transdermal Nicotine Patch
Description
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.
Time Frame
Up to 15 weeks
Title
Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary
Description
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)
Time Frame
up to 15 weeks
Title
Number of Patients Requiring Dose Reduction of Capecitabine
Description
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.
Time Frame
up to 24 weeks
Title
Number of Patients With Reported Use of Pain Medication for HFS
Description
Determine the number of patients requiring pain medication for the management of symptomatic HFS
Time Frame
Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year
Title
Number of Patients With Reported Use of Other Symptomatic Treatments for HFS
Description
Determine the number of patients utilizing additional treatments for symptomatic HFS. Additional treatments may include moisturizers, ice, and/or cooling packs
Time Frame
Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year
Title
Quality of Life as Measured by FACT-B Scale
Description
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.
Time Frame
Up to 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hope S. Rugo, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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