Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel

Stopped early · Not applicable

Conditions studied: Chemotherapeutic Agent Toxicity, Pain, Peripheral Neuropathy, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Therapy-related Toxicity

In brief

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.

Key facts

Study ID

NCT01243541

Run by

Northwestern University

People needed

33

Starts

2010-11-03

Expected to finish

2014-04-04

Last updated by the study team

2019-08-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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