Clinical trial NCT00751101: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Chemotherapeutic Agent Toxicity
Palmar-plantar Erythrodysesthesia
Keywords: palmar-plantar erythrodysesthesia
chemotherapeutic agent toxicity
stage IV breast cancer
recurrent breast cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2008-09-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Patients Who Developed Hand-foot Syndrome (HFS) by Toxicity Grade
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Frequency of Side Effects of the Transdermal Nicotine Patch
timeFrame: Up to 15 weeks
measure: Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary
timeFrame: up to 15 weeks
measure: Number of Patients Requiring Dose Reduction of Capecitabine
timeFrame: up to 24 weeks
measure: Number of Patients With Reported Use of Pain Medication for HFS
timeFrame: Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year
measure: Number of Patients With Reported Use of Other Symptomatic Treatments for HFS
timeFrame: Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year
measure: Quality of Life as Measured by FACT-B Scale
timeFrame: Up to 15 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Hope S. Rugo, MD
role: PRINCIPAL_INVESTIGATOR
References: