Evaluation of the efficacy of Frozen Glove to prevent peripheral neuropathy in patients who receive nab-paclitaxel treatment
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000007907
- Lead Sponsor
- Tokai Breast Cancer Clinical Research Group (TBCRG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1.HER2 IHC3+ or FISH positive 2.History of medication or cold allergies 3.Inflammatory breast cancer 4.Suspected brachial plexus neuropathy due to spread of breast cancer 5.Clinically significant edema of the arm on the affected side 6.History of other malignancy except carcinoma in situ within the last 5 years 7.Clinically significant central nervous system metastases 8.Clinically significant third space fluid accumulation (effusion, ascites, pericardial fluid ) 9.Active infection 10.Interstitial pneumonia or fibrosis of the lung 11.HBs antigen positive 12.Other concurrent severe and/or uncontrolled diabetes mellitus 13.Pregnant or nursing females 14.Not suitable for participation with any other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the rates of peripheral sensory neuropathy between protected and control hand. (Equal or more than PNQ Grade 2)
- Secondary Outcome Measures
Name Time Method Percentage of patients who carry nab-paclitaxel through four cycles Comparison of the rates of peripheral moter neuropathy(PNQ Grade) Comparison of the rates of peripheral sensory and moter neuropathy(PRO-CTCAE Grade) Comparison of the rates of peripheral sensory and moter neuropathy(CTCAE v4.0 Grade) Comparison of quantitative determination of peripheral sensory neuropathy with PAIN VISIO