Status:
TERMINATED
Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Breast Cancer
Chemotherapeutic Agent Toxicity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 red...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 20 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00751101
Start Date
August 20 2007
End Date
March 24 2018
Last Update
October 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94115