Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153282
• Other study ID #: UPCC 14110
• Status: Completed
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of interviews		2 years