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

NCT ID: NCT01243541

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-03
• Study Completion Date: 2014-04-04

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cryotherapy

Intervention Type: PROCEDURE

Patients wear an Elasto-Gel cold glove and sock

questionnaire administration

Intervention Type: OTHER

Ancillary studies

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

management of therapy complications

Intervention Type: PROCEDURE

In this therapeutic study, cold therapy is administered with an Elasto-Gel cold glove and sock (study device) that will be worn on your right hand and foot or your left hand and foot. The study device is a glycerine-based gel cold pack shaped like a mitten or sock with a cloth-like fabric kept at a constant temperature. The study device is not known to cause any major adverse affects and it is considered of non-significant risk. If you choose to participate in this study, you will be asked to wear a glove and sock at each paclitaxel infusion (4 treatments total). We hope the use of this study device will prevent or significantly reduce the onset and potential severity of paclitaxel-induced peripheral neuropathy and nail problems.

assessment of therapy complications

Intervention Type: PROCEDURE

Study Treatment Assessment You will be asked permission for pictures to be taken of only your hands and feet. This is to have a visual documentation of symptom development during your treatment. This will be done at all six time points before you begin chemotherapy that day.

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.

Group Type: EXPERIMENTAL

cryotherapy

Intervention Type: PROCEDURE

Patients wear an Elasto-Gel cold glove and sock

questionnaire administration

Intervention Type: OTHER

Ancillary studies

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary studies

management of therapy complications

Intervention Type: PROCEDURE

In this therapeutic study, cold therapy is administered with an Elasto-Gel cold glove and sock (study device) that will be worn on your right hand and foot or your left hand and foot. The study device is a glycerine-based gel cold pack shaped like a mitten or sock with a cloth-like fabric kept at a constant temperature. The study device is not known to cause any major adverse affects and it is considered of non-significant risk. If you choose to participate in this study, you will be asked to wear a glove and sock at each paclitaxel infusion (4 treatments total). We hope the use of this study device will prevent or significantly reduce the onset and potential severity of paclitaxel-induced peripheral neuropathy and nail problems.

assessment of therapy complications

Intervention Type: PROCEDURE

Study Treatment Assessment You will be asked permission for pictures to be taken of only your hands and feet. This is to have a visual documentation of symptom development during your treatment. This will be done at all six time points before you begin chemotherapy that day.

Interventions

cryotherapy

Patients wear an Elasto-Gel cold glove and sock

Intervention Type: PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type: OTHER

quality-of-life assessment

Ancillary studies

Intervention Type: PROCEDURE

management of therapy complications

In this therapeutic study, cold therapy is administered with an Elasto-Gel cold glove and sock (study device) that will be worn on your right hand and foot or your left hand and foot. The study device is a glycerine-based gel cold pack shaped like a mitten or sock with a cloth-like fabric kept at a constant temperature. The study device is not known to cause any major adverse affects and it is considered of non-significant risk. If you choose to participate in this study, you will be asked to wear a glove and sock at each paclitaxel infusion (4 treatments total). We hope the use of this study device will prevent or significantly reduce the onset and potential severity of paclitaxel-induced peripheral neuropathy and nail problems.

Intervention Type: PROCEDURE

assessment of therapy complications

Study Treatment Assessment You will be asked permission for pictures to be taken of only your hands and feet. This is to have a visual documentation of symptom development during your treatment. This will be done at all six time points before you begin chemotherapy that day.

Intervention Type: PROCEDURE

Other Intervention Names

quality of life assessment; complications of therapy, management of

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Paice, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2010-02105

Identifier Type: -

Identifier Source: secondary_id

STU00033028

Identifier Type: OTHER

Identifier Source: secondary_id

NU 10CC03

Identifier Type: -

Identifier Source: org_study_id