Status:
COMPLETED
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-70 years
Brief Summary
Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01153282
Start Date
June 1 2010
End Date
May 1 2012
Last Update
March 10 2020
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104