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

Completed · Not applicable

Conditions studied: Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT02640053

Run by

Academic and Community Cancer Research United

People needed

46

Starts

2015-12-23

Expected to finish

2018-10-05

Last updated by the study team

2019-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Carle Cancer Center NCI Community Oncology Research Program — Urbana, Illinois, United States
• Cancer Research Consortium of West Michigan NCORP — Grand Rapids, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• AnMed Health Cancer Center — Anderson, South Carolina, United States
• Bon Secours Saint Francis Hospital — Charleston, South Carolina, United States
• Spartanburg Medical Center — Spartanburg, South Carolina, United States
• Rapid City Regional Hospital — Rapid City, South Dakota, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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