Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome

PRIMARY OBJECTIVES:

I. To estimate whether topical cryotherapy can alleviate paclitaxel-induced peripheral
neuropathy.

II. To estimate whether topical cryotherapy can alleviate paclitaxel-induced acute pain
syndrome (P-APS).

III. To examine the possible relative toxicities related to topical cryotherapy in this study
situation.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients apply bags filled with crushed ice to hands and feet for 15 minutes before,
for 60 minutes during administration, and for 15 minutes after finishing administration of
paclitaxel.

ARM II: Patients receive paclitaxel intravenously (IV) over 60 minutes on weeks 1-12.

In both arms, courses repeat once a week for 12 weeks in the absence of disease progression
or unacceptable toxicity.

After completion of study treatment, patients are followed up every 30 days for 6 months.

Inclusion Criteria:

- Ability to complete questionnaires by themselves or with assistance

- Planned paclitaxel at a dose of 80 mg/m^2 intravenously (I.V.) given, in the adjuvant
breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course
of 12 weeks without any other concurrent cytotoxic chemotherapy (NOTE: trastuzumab
and/or other antibody and/or small molecule treatment is allowed, except for poly
adenosine diphosphate ribose polymerase [PARP] inhibitors), at the entering Academic
and Community Cancer Research United (ACCRU) institution

- Life expectancy > 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Patient has score of 0 or 1 on the neurotoxicity evaluation, as determined by the
healthcare provider

Exclusion Criteria:

- Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause

- Diagnosis of fibromyalgia

- Any prior exposure to neurotoxic chemotherapy

- History of Raynaud?s disease, cryoglobulinemia