Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01153282
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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 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 taxanes.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of interviews	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States