Clinical trial NCT01243541: Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
Official title: Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-18
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
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.
timeFrame: Periodically during study treatment
measure: To compare the treated or untreated extremities with respect to the percentage having score values of 4 or greater.
timeFrame: After completion of study treatment
Secondary outcomes:
measure: 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.
timeFrame: Periodically during study treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Judith Paice, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: