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

NCT00751101 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 057514ROCHE-UCSF-057514NCI-2011-03236
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Chemotherapeutic Agent Toxicity; Palmar-plantar Erythrodysesthesia

Keywords

palmar-plantar erythrodysesthesia; chemotherapeutic agent toxicity; stage IV breast cancer; recurrent 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

• Number of Patients Requiring Dose Reduction of Capecitabine

  up to 24 weeks

• Number of Patients With Reported Use of Pain Medication for HFS

  Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year

• Number of Patients With Reported Use of Other Symptomatic Treatments for HFS

  Until last dose of capecitabine treatment or HFS has resolved, approximately 1 year

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 patch 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 A: Prior to initiation of capecitabine; Arm B: After hand-foot syndrome symptoms appear

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hand-Foot Syndrome

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Drug Eruptions; Dermatitis; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

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

Hope.Rugo@ucsf.edu

(415) 353-7618

Study Officials

• Hope S. Rugo, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Primary Completion: March 24, 2014
• Study Completion: March 24, 2018
• Last Updated: October 5, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)