Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study)
Phase 3
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000024836
- Lead Sponsor
- Kamigata Breast Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 61
Inclusion Criteria
Not provided
Exclusion Criteria
1)have any peripheral sensory / motor neuropathy (CTCAE ver4.0) 2)received previous chemotherapy 3) Multiple primary cancer. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer 4) Synchronous bilateral breast cancer 5) Brain metastasis 6) Poorly controlled complication (infection, diabetes mellitus, and others)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of nab-paclitaxel-induced peripheral neuropathy of grade 2 or higher
- Secondary Outcome Measures
Name Time Method 1) The evaluation of nab-paclitaxel-induced PN by using the Patient Neurotoxicity Questionnaire (we call PNQ) 2) The changes in the temperature of each fingertip 3) Withdrawal rate of wearing sutgical gloves 4) Adverse events of wearung surgical gloves