Trial Information

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

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.