Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
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ClinicalTrials.gov Identifier: NCT01243541 |
Recruitment Status :
Terminated
(PI decision due to low accrual and lack of funding)
First Posted : November 18, 2010
Last Update Posted : August 20, 2019
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Condition or disease | Intervention/treatment | Phase |
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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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity |
Actual Study Start Date : | November 3, 2010 |
Actual Primary Completion Date : | April 4, 2014 |
Actual Study Completion Date : | April 4, 2014 |

Arm | Intervention/treatment |
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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.
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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. |
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243541
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Judith Paice, PhD, RN | Northwestern University |
Responsible Party: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT01243541 History of Changes |
Other Study ID Numbers: |
NU 10CC03 NCI-2010-02105 STU00033028 ( Other Identifier: Northwestern University IRB ) |
First Posted: | November 18, 2010 Key Record Dates |
Last Update Posted: | August 20, 2019 |
Last Verified: | August 2019 |
Breast Neoplasms Peripheral Nervous System Diseases Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neuromuscular Diseases Nervous System Diseases |
Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |