Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

NCT ID: NCT01153282

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-05-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela DeMichele, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 14110

Identifier Type: -

Identifier Source: org_study_id