Clinical trial · Interventional
Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer
Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome Associated With Capecitabine Chemotherapy in Patients With Metastatic Breast Cancer
NCT00751101CI-TRIAL-00047463terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Palmar-plantar Erythrodysesthesia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nicotine patch | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Prior to initiation of capecitabine
- 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.
- interventionNames
- Drug: Nicotine patch
- type
- EXPERIMENTAL
- label
- Arm B: After hand-foot syndrome symptoms appear
- 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.
- interventionNames
- Drug: Nicotine patch
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.