Breast cancer
Conditions
Interventions
Frozen Glove attach to the hand and foot of the patients on the diseased side during infusion of nab-paclitaxel. Control: healthy side
Sponsors
Tokai Breast Cancer Clinical Research Group (TBCRG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed primary breast cancer 2.Metastatic or recurrent breast cancer 3.No prior chemotherapy except adjuvant therapy, with paclitaxel or nab-paclitaxel 4.No peripheral neuropathy (PNQ<=1) 5.Adequate organ function shown in physical examinations within 14 days prior to enrollment Neutrophil count >=2000/mm3 Platelet count >=100,000/mm3 Hemoglobin >=9.0g/dL AST and ALT <=2.5 x upper limit of normal (ULN) Total serum bilirubin <=l.5 xULN Serum creatinine <=1.5 xULN 6.Electrocardiographic abnormality 7.Age of 20-75 years 8.ECOG PS 0-2
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the rates of peripheral sensory neuropathy between protected and control hand. (Equal or more than PNQ Grade 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 VISION | — |
Countries
Japan
Contacts
Public ContactMD PhD
Kanagawa Cancer Center Department of Breast and Endocrine Surgery
Outcome results
None listed