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

Purpose

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.

Condition	Intervention
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	Procedure: cryotherapy Other: questionnaire administration Procedure: quality-of-life assessment Procedure: management of therapy complications Procedure: assessment of therapy complications

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Breast Cancer Cancer Foot Health Peripheral Nerve Disorders

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

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. [ Time Frame: Periodically during study treatment ] [ Designated as safety issue: No ]
To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater. [ Time Frame: After completion of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Periodically during study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	October 2010
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Procedure: cryotherapy Patients wear an Elasto-Gel cold glove and sock Other: questionnaire administration Ancillary studies Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment 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. Other Name: complications of therapy, management of 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.
Experimental: 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.	Procedure: cryotherapy Patients wear an Elasto-Gel cold glove and sock Other: questionnaire administration Ancillary studies Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment 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. Other Name: complications of therapy, management of 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.

Arms

Assigned Interventions

Experimental: 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.

Procedure: cryotherapy

Patients wear an Elasto-Gel cold glove and sock

Other: questionnaire administration

Ancillary studies

Procedure: quality-of-life assessment

Ancillary studies

Other Name: quality of life assessment

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.

Other Name: complications of therapy, management of

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.

Experimental: 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.

Procedure: cryotherapy

Patients wear an Elasto-Gel cold glove and sock

Other: questionnaire administration

Ancillary studies

Procedure: quality-of-life assessment

Ancillary studies

Other Name: quality of life assessment

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.

Other Name: complications of therapy, management of

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243541

Locations

United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Judith Pace 312-695-4550 J-Paice@northwestern.edu
Principal Investigator: Judith Paice, PhD, RN
Sub-Investigator: Virginia Kaklamani, MD
Sub-Investigator: R. N. Harden, MD

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Judith Paice, PhD, RN

Northwestern University

More Information

No publications provided

Responsible Party:	Northwestern University
ClinicalTrials.gov Identifier:	NCT01243541 History of Changes
Other Study ID Numbers:	NU 10CC03, NCI-2010-02105, STU00033028
Study First Received:	October 29, 2010
Last Updated:	March 22, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Peripheral Nervous System Diseases
Breast Neoplasms
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases

Signs and Symptoms
Poisoning
Substance-Related Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013