Pain Clinical Trial
Official title:
Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity
Verified date | August 2019 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Cryotherapy may help prevent peripheral neuropathy or nail toxicity in patients receiving chemotherapy. PURPOSE: This clinical trial studies cryotherapy in preventing peripheral neuropathy and nail toxicity in patients with breast cancer who are receiving paclitaxel.
Status | Terminated |
Enrollment | 33 |
Est. completion date | April 4, 2014 |
Est. primary completion date | April 4, 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the primary aim of the study to determine the differences in "tingling" and "numbness" (measured on a 0-10 numeric rating scale) between the treated and untreated extremities. | Periodically during study treatment | ||
Primary | To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater. | After completion of study treatment | ||
Secondary | To compare the treated and untreated extremities at each time point with respect to the ratings in regards to the NCI-CTC v4.0, BPI, and QSTs. | Periodically during study treatment |
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