A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-UMIN000030536
- Lead Sponsor
- Department of Outpatient Oncology Unit, Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
With allergy for material of frozen globe and surgical glove Patients with neuropathic pain due to diseases such as diabetes and herpes zoster
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of grade 2 or higher nab-paclitaxel-induced peripheral neuropathy. Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy.
- Secondary Outcome Measures
Name Time Method 1.Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy with historical control. 2.Withdrawal of intervention procedures 3.Adverse events of interventional procedures 4.Factors affecting nab-paclitaxel-induced peripheral neuropathy (clinical background, administration of analgesic adjuvant, involvement of dominant hand, etc.) 5.The evaluation of nab-paclitaxel-induced peripheral neuropathy by using the Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy.