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Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

21 Years
70 Years
Not Enrolling
Breast Cancer

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Trial Information

Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Taxanes, a type of chemotherapeutic agent prescribed to breast cancer patients, have a known
physical side effect of chemotherapy induced peripheral neuropathy (CIPN). The purpose of
this qualitative study is to understand the experience and physical functional side effects
of taxanes. This is the first of a two phase study. The overall goal is to identify
existing objective physical performance measures to assess functional side effects of

Inclusion Criteria:

- Women 21-70 years old (Women over 70 are offered chemotherapy less frequently because
of their risk benefit ratio. Including them would be a selection bias because of
their differential underexposure).

- Initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously
untreated metastatic setting.

- The range of exposure to taxane-based chemotherapy will include women on active
treatment having received two cycles, to women who are within three months of their
last infusion.

- Documented symptoms of CIPN per CTCAE grading criteria (half of sample) or NO
symptoms (half of sample) Grade 0 = no CIPN symptoms Grade 1 = mild symptoms Grade 2
= moderate symptoms - prescribed Gabapentin (Neurontin) Grade 3&4= severe symptoms -
treated with Gabapentin (Neurontin), treatment plan altered

Exclusion Criteria:

- Physical disabilities - defined by use of assistive devices to complete functional
tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy.

- Current exposure to neurotoxic agents (Navelbine, platinums or other taxanes)

- Pregnancy during chemotherapy treatment

- Diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically
established neuropathy

- Previous exposure to chemotherapy or radiotherapy

- HIV positive (high risk for neuropathy)

- Other neurological diseases, such as Multiple Sclerosis

- Other pre-existing neuropathy

Type of Study:


Study Design:


Principal Investigator

Rebecca Speck, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Institutional Review Board

Study ID:

UPCC 14110



Start Date:

June 2010

Completion Date:

April 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer patients
  • Breast Neoplasms



Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283