Clinical trial NCT01153282: Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
Official title: Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer patients
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 25
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The semi-structured interviews will be conducted with breast cancer patients of the Rena Rowan Breast Center of the Abramson Cancer Center of the University of Pennsylvania. A purposive sampling strategy in which study participants are recruited based on a particular characteristic of experience of interest, will be used to select breast cancer patients (N=30). Participants will be recruitedwith the goal of having a balanced sample of women who experience documented CIPN (per Common Toxicity Criteria for Adverse Events CTCAE - grading criteria, details below) and those who received a taxane but did not have documented CIPN.

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.

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

Primary outcomes:
measure: Number of interviews
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Angela DeMichele, MD
role: PRINCIPAL_INVESTIGATOR
References: