chemotherapy-induced peripheral neuropathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed history of stage I-III breast cancer with no evidence of distant metastasis; 2. Plan to receive adjuvant or neoadjuvant taxane-based chemotherapy (direct treatment with or without HER-2 or immunotherapy with or without immunotherapy). Patients must be enrolled before the second taxane cycle; 3, age =18; 4. ECOG status is 0 or 1;
Exclusion criteria
Exclusion criteria: 1.Previous CIPN-induced chemotherapeutic drugs (1 previous taxane cycle allowed); 2. Unstable heart disease or myocardial infarction within 6 months before entering the study; 3, wear a pacemaker or implantable cardioverter defibrillator; 4. Uncontrollable seizures; 5. Previous history of peripheral neuropathy; 6. Use acupuncture within 3 months before study registration; 7. Self-report of any CIPN symptoms by staff managed PRO-CTCAE CIPN is defined as: report of PRO-CTCAE CIPN severity items as "light", "medium", "severe", "extremely severe".
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate;EORTC QLQ-CIPN20;The severity of neuropathy(CTCAE V5.0); | — |
Secondary
| Measure | Time frame |
|---|---|
| NCS;Cancer Quality of Life Core Scale QLQ-C30;Pain Numerical Rating Scale (NRS);Grading Criteria for Peripheral Neuropathy (NCI-CTCAE V5.0);Castillo Functional Status (KPS);Pittsburgh Sleep Scale;TCM syndrome scale; | — |
Countries
China
Contacts
Jiangsu Hospital of Traditional Chinese Medicine