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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01243541
First Posted: November 18, 2010
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
October 29, 2010
November 18, 2010
March 3, 2017
October 2010
October 2017   (Final data collection date for primary outcome measure)
  • 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 ]
  • Differences in "tingling" and "numbness" between treated and untreated extremities [ Time Frame: During each study treatment visit which is every 2 weeks ]
    To determine the 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)
  • Percentage comparison between the treated or untreated extremities [ Time Frame: After completion of study which is 2 weeks after the last treatment ]
    To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater.
Complete list of historical versions of study NCT01243541 on ClinicalTrials.gov Archive Site
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 ]
  • Comparison of treated and untreated extremities in regards to the NCICTC v4.0 [ Time Frame: During each study treatment visit which is every 2 weeks ]
    To compare, during each visit for study treatment, the treated and untreated extremities at each time point with respect to the ratings in regards to the NCICTC v4.0, BPI, and QSTs.
  • Comparison of treated and untreated extremities in regards to the BPI [ Time Frame: During each study treatment visit which is every 2 weeks ]
    To compare, during each visit for study treatment, the treated and untreated extremities at each time point with respect to the ratings in regards to the NCICTC v4.0, BPI, and QSTs.
  • Comparison of treated and untreated extremities in regards to the QSTs [ Time Frame: During each study treatment visit which is every 2 weeks ]
    To compare, during each visit for study treatment, the treated and untreated extremities at each time point with respect to the ratings in regards to the NCICTC v4.0, BPI, and QSTs.
Not Provided
Not Provided
 
Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • 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
    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 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.
    Interventions:
    • Procedure: cryotherapy
    • Other: questionnaire administration
    • Procedure: quality-of-life assessment
    • Procedure: management of therapy complications
    • Procedure: assessment of therapy complications
  • 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.
    Interventions:
    • Procedure: cryotherapy
    • Other: questionnaire administration
    • Procedure: quality-of-life assessment
    • Procedure: management of therapy complications
    • Procedure: assessment of therapy complications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
October 2018
October 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01243541
NU 10CC03
NCI-2010-02105
STU00033028 ( Other Identifier: Northwestern University IRB )
Yes
Not Provided
Not Provided
Northwestern University
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: Judith Paice, PhD, RN Northwestern University
Northwestern University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP