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

NCT ID: NCT00751101

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-20
• Study Completion Date: 2018-03-24

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.

Conditions

Breast Cancer; Chemotherapeutic Agent Toxicity; Palmar-plantar Erythrodysesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nicotine patch

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Nicotine patch

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hope S. Rugo, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

ROCHE-UCSF-057514

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-03236

Identifier Type: REGISTRY

Identifier Source: secondary_id

057514

Identifier Type: -

Identifier Source: org_study_id