Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

NCT01153282 | Completed DMC

• 1 other identifier: UPCC 14110
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast Cancer patients

Outcome Measures

Primary Outcomes (1)

• Number of interviews

  2 years

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Angela DeMichele, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

US (1)