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

Not Applicable

Terminated

• Conditions: Stage IIIB Breast Cancer; Stage IB Breast Cancer; Stage IIIC Breast Cancer; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IIIA Breast Cancer; Therapy-related Toxicity; Peripheral Neuropathy; Chemotherapeutic Agent Toxicity; Pain
• Interventions: Procedure: cryotherapy; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: management of therapy complications; Procedure: assessment of therapy complications

• Registration Number: NCT01243541
• Lead Sponsor: Northwestern University

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 and nail toxicity in patients with breast cancer who are receiving paclitaxel.

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-10-29
• Study Start: 2010-11-03
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2014-04-04
• Study Completion: 2014-04-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	cryotherapy	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 I	questionnaire administration	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 I	quality-of-life assessment	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 I	assessment of therapy complications	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	cryotherapy	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.
Arm II	questionnaire administration	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.
Arm II	assessment of therapy complications	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.
Arm I	management of therapy complications	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	quality-of-life assessment	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.
Arm II	management of therapy complications	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.

Primary Outcome Measures

Name	Time	Method
To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater.	After completion of study treatment
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States