- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01243541
Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
August 16, 2019 updated by: Northwestern University
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.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Ancillary studies
Ancillary studies
Other Names:
Patients wear an Elasto-Gel cold glove and sock
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 Names:
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.
|
Ancillary studies
Ancillary studies
Other Names:
Patients wear an Elasto-Gel cold glove and sock
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 Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
After completion of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Periodically during study treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2010
Primary Completion (Actual)
April 4, 2014
Study Completion (Actual)
April 4, 2014
Study Registration Dates
First Submitted
October 29, 2010
First Submitted That Met QC Criteria
November 17, 2010
First Posted (Estimate)
November 18, 2010
Study Record Updates
Last Update Posted (Actual)
August 20, 2019
Last Update Submitted That Met QC Criteria
August 16, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU 10CC03
- NCI-2010-02105
- STU00033028 (Other Identifier: Northwestern University IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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