Status:
TERMINATED
Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chemotherapeutic Agent Toxicity
Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing peripheral neuropathy ...
Detailed Description
PRIMARY OBJECTIVES: I. Differences in "tingling" and "numbness" (measured on 0-10 numeric rating scale; as measured by NPSI) between treated and untreated extremities at conclusion of paclitaxel thera...
Eligibility Criteria
Inclusion
- Women with histologically confirmed diagnosis of breast cancer (any stage)
- Must be receiving either adjuvant or neo-adjuvant dose-dense anthracycline/taxane-based chemotherapy
- Specifically, this study seeks to characterize neuropathies associated with patients receiving paclitaxel cycles separated by two week intervals
- Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation
- Prior chemotherapies are permitted, except with prior treatments with taxanes
- Required lab values: CBC, Comprehensive Chemistry Panel
- Desired lab values: If the patient's record also includes TSH, HbA1c, and folate, then those will be recorded as well
- All patients will have given signed, informed consent prior to registration
Exclusion
- Patients must not have received any prior taxane treatments
- Patients must not have a history of peripheral neuropathy (regardless of cause)
- Patient must not have a history of diabetes mellitus
- Patient must not have a history of Raynaud's disease
- Men are not eligible
Key Trial Info
Start Date :
November 3 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01243541
Start Date
November 3 2010
End Date
April 4 2014
Last Update
August 20 2019
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611