Spots Global Cancer Trial Database for Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome

Study Description

Brief Summary: This randomized pilot clinical trial studies topical cryotherapy (cooling hands and feet with ice bags) in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy is being studied to see if it can help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

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