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

Northwestern University

Status: Terminated

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

Treatments: Procedure: quality-of-life assessment; Procedure: management of therapy complications; Other: questionnaire administration; Procedure: cryotherapy; Procedure: assessment of therapy complications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01243541

NCI-2010-02105

NU 10CC03

STU00033028 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 therapy). SECONDARY OBJECTIVES: I. Differences in nail toxicity between treated and untreated extremities as measured by NCI-CTC v4.0 from baseline to conclusion of taxane therapy and at each time point (after each infusion and at conclusion of taxane therapy). II. Differences in peripheral sensory neuropathy subscale of NCI-CTC v 4.0 between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). III. Differences in pain intensity (0-10 from BPI) between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). IV. Differences in quantitative sensory testing between treated and untreated extremities at each time point (after each infusion and at conclusion of paclitaxel therapy). OUTLINE: Patients are randomized to 1of 2 treatment arms. ARM I. Patients wear an Elasto-Gel cold glove and sock on their dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel.The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. ARM II: Patients wear an Elasto-Gel cold glove and sock on their non-dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel. The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes. In both arms, treatment repeats every 2 weeks for 4 courses in the absences of unacceptable toxicity.

Enrollment: 33 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients wear an Elasto-Gel cold glove and sock on their dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel.The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes.

Treatment:

Procedure: management of therapy complications

Procedure: quality-of-life assessment

Procedure: cryotherapy

Procedure: assessment of therapy complications

Other: questionnaire administration

Arm II

Experimental group

Description:

Patients wear an Elasto-Gel cold glove and sock on their non-dominant hand and foot every two weeks on days the patient is scheduled for paclitaxel. The glove and sock is worn for 15 minutes prior to paclitaxel infusion, 3 hours during treatment, and for 15 minutes after completion of chemotherapy for a total of 210 minutes.

Treatment:

Procedure: management of therapy complications

Procedure: quality-of-life assessment

Procedure: cryotherapy

Procedure: assessment of therapy complications

Other: questionnaire administration