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Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01153282
First received: June 28, 2010
Last updated: April 6, 2011
Last verified: April 2011

June 28, 2010
April 6, 2011
June 2010
April 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01153282 on ClinicalTrials.gov Archive Site
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Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

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

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.

Observational
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Probability Sample

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.

Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Female
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01153282
UPCC 14110
Yes
Rebecca Speck, Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
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Principal Investigator: Rebecca Speck, MPH Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP