Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01153282

Enrollment

Registered

2010-06-30

Start date

2010-06-30

Completion date

2012-05-31

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer patients

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of interviews	2 years

Countries

United States

Outcome results