Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
This trial is active, not recruiting.
|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|
|Treatments||cryotherapy, questionnaire administration, quality-of-life assessment, management of therapy complications, assessment of therapy complications|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2010|
|End date||October 2017|
|Trial size||66 participants|
|Trial identifier||NCT01243541, NCI-2010-02105, NU 10CC03, STU00033028|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
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
Female participants at least 18 years old.
- 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
- 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
|Official title||Cold Therapy to Prevent Paclitaxel-Induced Peripheral Neuropathy and Cutaneous Toxicity|
|Principal investigator||Judith Paice, PhD, RN|
|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.|
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