NCT02640053

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

Pilot Clinical Trial Evaluating the Utility of Topical Cryotherapy to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Cryotherapy	Applied topically
DRUG	Paclitaxel	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-12-23
• Primary completion: 2017-09-05
• Completion: 2018-10-05
• First posted: 2015-12-28
• Last updated: 2019-09-30
• Results posted: 2018-10-05

Locations

8 sites across 1 country: United States