Breast Cancer Clinical Trial
Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome
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.
Full 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.
Eligibility Criteria
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
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There are 8 Locations for this study
Urbana Illinois, 61801, United States
Grand Rapids Michigan, 49503, United States
Rochester Minnesota, 55905, United States
Anderson South Carolina, 29621, United States
Charleston South Carolina, 29414, United States
Spartanburg South Carolina, 29303, United States
Rapid City South Dakota, 57701, United States
Marshfield Wisconsin, 54449, United States
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