Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
Completed
Conditions studied: Breast Cancer
In brief
Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.
Key facts
- Study ID
- NCT01153282
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 25
- Starts
- 2010-06-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2020-03-10
Who can join
Age: 21 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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