Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Chemotherapeutic Agent Toxicity Palmar-plantar Erythrodysesthesia

Keywords

palmar-plantar erythrodysesthesiachemotherapeutic agent toxicitystage IV breast cancerrecurrent breast cancer

Outcome Measures

Primary Outcomes (1)

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.
up to 24 weeks

Secondary Outcomes (6)

Frequency of Side Effects of the Transdermal Nicotine Patch
Up to 15 weeks
Compliance in Using the Transdermal Nicotine Patch as Measured by Patient Diary
up to 15 weeks

Study Arms (2)

Arm A: Prior to initiation of capecitabine

EXPERIMENTAL

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.

Drug: Nicotine patch

Arm B: After hand-foot syndrome symptoms appear

EXPERIMENTAL

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.

Drug: Nicotine patch

Interventions

Nicotine patchDrug

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 A: Prior to initiation of capecitabineArm B: After hand-foot syndrome symptoms appear

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

Hoffmann-La Roche
Industrycollaborator
University of California, San Francisco
Otherlead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

MeSH Terms

Conditions

Breast NeoplasmsHand-Foot Syndrome

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDrug EruptionsDermatitisDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Limitations and Caveats

Study terminated earlier than expected due to low accrual

Results Point of Contact

Title: Dr. Hope Rugo, MD
Organization: University of California, San Francisco

Study Officials

Hope S. Rugo, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

August 20, 2007

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Arm A: Prior to initiation of capecitabine

Arm B: After hand-foot syndrome symptoms appear

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Arm A: Prior to initiation of capecitabine

Arm B: After hand-foot syndrome symptoms appear

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations