Breast Cancer
Conditions
Interventions
None listed
Sponsors
Kyoto Breast Cancer Research Network (KBCRN)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Pathological Diagnosis of invasive ductal carcinoma of Breast cancer 2)Primary, advanced or recurrent cancer patients planning to receive more than 12cycles of weekly Paclitaxel therapy (weekly Paclitaxel with Trastuzumab and Pertuzumab included), or PTX+Bevacizmab more than 3cycle, or nab-PTX more than 4cycle 3)ECOG Scale 0 or 1 4)Non ECG abnormality 5)No obvious interstitial pneumonia or pulmonary fibrosis on chest X-ray or CT
Exclusion criteria
Exclusion criteria: 1)Patients who have CTCAE more than grade1 neuropathy and/or skin disorders 2)Patients taking pregabalin, etc. to control neuropathic pain 3)active double cancer (except lesions corresponding to carcinoma in situ or intramucosal cancer that are judged to be cured by local treatment are not included in the double cancer). 4)active brain metastasis 5)Diabetes mellitus with peripheral neuropathy, infectious diseases (on limbs) that are judged to interfere with prevention, and other serious complications are observed. 6)History of severe drug hypersensitivity in therapeutically important drugs in this study 7)History of serious mental illness or under treatment 8)HBsAg positive and untreated 9)History of serious heart or respiratory illness 10)May be pregnant or pregnant 11)In addition, when the principal investigator or the research coordinator determines that the subject is inappropriate (specific example: signs of peripheral circulatory insufficiency such as Raynaud's phenomenon)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Incidence of CIPN:Score of hands in Patient Neurotoxicity Questionnaire (PNQ) 2)Incidence of CIPN in hands:CTCAE grade over 2 3)Incidence of CIPN:Score of feet in PNQ 4)Incidence of CIPN in feet:CTCAE grade over 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Number of cycles to CIPN PNQ Score D 2)Number of cycles to CIPN CTCAE grade over 2 3)Incidence of CIPN in hands and feet 4) Incidence of CIPN in hands and feet till the date of primary endpoint by CTCAE 5) Time to CIPN PNQ score over D in hands 6) Incidence and Time to CIPN of CTCAE Grade over 2 in hands 7) Time to CIPN PNQ score over D in feet 8) Incidence and Time to CIPN of CTCAE Grade over 2 in feet 9) Finger dexterity with Grooved pegboard test 10) Tactile sense by Semmes-Weinstein monofilament Test 11)Incidence and Time to Skin and subcutaneous tissue disorders 12) Temperature of hands and feet before and after compression or cryotherapy 13) Incidence of cases dropping out 14) Pressure of ECGS 15) Time to prescription for CIPN 16) Fall frequency 17) PNQ by electronic Patient Reported Outcome 18) Diary by electronic Patient Reported Outcome | — |
Countries
Japan
Contacts
Public ContactNorihiko Kitamura
Kyoto Breast Cancer Research Network (KBCRN) -
Outcome results
None listed