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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
History of Changes
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
Official Title: Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Estimated Enrollment: 30
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153282

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Rebecca Speck, MPH Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Rebecca Speck, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01153282     History of Changes
Other Study ID Numbers: UPCC 14110
Study First Received: June 28, 2010
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Breast Cancer patients

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 13, 2013