Cryotherapy in Preventing Peripheral Neuropathy and Nail Toxicity in Patients With Breast Cancer Who Are Receiving Paclitaxel
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Chronic Pain, Neurology |
| Therapuetic Areas: | Musculoskeletal, Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2018 |
| Start Date: | October 2010 |
| End Date: | October 2020 |
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.
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.
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.
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
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