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

Pain Clinical Trial

Official title:

Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01243541
• Other study ID #: NU 10CC03
• Secondary ID: NCI-2010-02105ST
• Status: Terminated
• Phase: N/A
• Start date: November 3, 2010
• Est. completion date: April 4, 2014

Study information

• Verified date: August 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: April 4, 2014
• Est. primary completion date: April 4, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapeutic Agent Toxicity
• Pain
• Peripheral Nervous System Diseases
• 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

Intervention

Procedure:
• cryotherapy
Patients wear an Elasto-Gel cold glove and sock

Other:
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies
• 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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Periodically during study treatment
Primary	To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater.		After completion of study treatment
Secondary	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.		Periodically during study treatment