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Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome Associated With Capecitabine Chemotherapy in Patients With Metastatic Breast Cancer


N/A
18 Years
75 Years
Open (Enrolling)
Both
Breast Cancer, Chemotherapeutic Agent Toxicity, Palmar-plantar Erythrodysesthesia

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Trial Information

Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome Associated With Capecitabine Chemotherapy in Patients With Metastatic Breast Cancer


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of breast cancer

- Metastatic disease

- Scheduled to begin treatment with capecitabine at the 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Incidence and severity of hand-foot syndrome (HFS) as measured by NCI CTCAE v3.0

Safety Issue:

No

Principal Investigator

Hope S. Rugo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000613046

NCT ID:

NCT00751101

Start Date:

August 2007

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Chemotherapeutic Agent Toxicity
  • Palmar-Plantar Erythrodysesthesia
  • palmar-plantar erythrodysesthesia
  • chemotherapeutic agent toxicity
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115