Metastatic breast cancer
Conditions
Interventions
Intervention group:True acupuncture, mecobalamin and duloxetine
Control group:Sham acupuncture, mecobalamin and duloxetine
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Before enrollment, all participants should willingly sign an informed consent. 2. Chinese women aged 18 to 70 years old, regardless of ethnicity. 3. Pathologically diagnosed with metastatic breast cancer, who have received or are currently receiving neurotoxic chemotherapy such as taxanes (especially albumin paclitaxel) and utidelone, and have moderate to severe CIPN symptoms (CTCAE V5.0 grade 2 or 3), such as numbness, pain and muscle weakness. 4. The general condition and physical fitness of the participant are good, with an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2. 5. The expected lifespan of the participant is = 3 months. 6. The laboratory basic examinations and tests of the participant' bone marrow hematopoietic function, coagulation function, liver and kidney function, etc. are normal.
Exclusion criteria
Exclusion criteria: 1. The participant did not sign or voluntarily withdraw the informed consent form. 2. The participant had poor physical condition, with an ECOG score of = 3. 3. The participant had an expected lifespan of less than 3 months. 4. The participant had not received chemotherapy treatment with known CIPN effects, or had contraindications to chemotherapy as assessed by the researchers. 5. The participant did not have CIPN symptoms (i.e., CTCAE V5.0 grade 1), or had CIPN symptoms of CTCAE V5.0 grades 4 or 5 (life-threatening or fatal). 6. According to the assessment by the researchers, the participant's neurological symptoms might be caused by diabetes or other diseases. 7. Before enrollment, the participant had received any CIPN treatment other than the study protocol and had not undergone drug desensitization. 8. The participant had a previous history of neurological and mental disorders (such as epilepsy, delirium, dementia, schizophrenia, etc.), and were unable to cooperate with the relevant intervention measures and follow-up. 9. The participant is allergic to stainless steel needles, mecobalamin, or duloxetine. 10. There are or are expected to be lymphedema, inflammatory reactions, or wounds at the acupuncture site and the corresponding limb during the study. 11. Laboratory indicators are significantly abnormal, including white blood cells, neutrophils, platelets, coagulation function, transaminases, bilirubin, creatinine, urea nitrogen, etc. 12. During the entire study period, they are currently or plan to be pregnant or breastfeeding. 13. There are other potential risks or other conditions that make them unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 6 weeks of enrollment, the NRS score for the overall pain and numbness symptoms of the subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Six weeks after enrollment, other assessment indicators of the overall CIPN symptoms in the subjects (LANSS, EORTC QLQ-CPN20 and CTCAE grading);Six weeks after enrollment, the assessment indicators of non-surgical side upper limb CIPN symptoms (NRS, LANSS and CTCAE grading) of the subjects;After 6 weeks of enrollment, the assessment indicators of lower extremity CIPN symptoms (NRS, LANSS and CTCAE grading) of the subjects;After 6 weeks of enrollment, the assessment indicators (NRS, LANSS, EORTC QLQ-CPN20 and CTCAE grading) for overall CIPN symptoms in the subgroup of subjects treated with utidelone;After 6 weeks of enrollment, the assessment indicators (NRS, LANSS, EORTC QLQ-CPN20 and CTCAE grading) for overall CIPN symptoms in the subgroup of subjects treated with taxanes;After 6 weeks of enrollment, the proportion of complete pain alleviation;After 6 weeks of enrollment, the proportion of complete numbness alleviation;After 6 weeks of enrollment, the proportion of complete muscle strength restoration;One week after enrollment, the assessment indicators of overall CIPN symptoms in the subjects (NRS, LANSS, EORTC QLQ-CPN20 and CTCAE grading);Three weeks after enrollment, the assessment indicators of overall CIPN symptoms in the subjects (NRS, LANSS, EORTC QLQ-CPN20 and CTCAE grading);After nine weeks of enrollment, the assessment indicators (NRS, LANSS, EORTC QLQ-CPN20 and CTCAE grading) for overall CIPN symptoms in the subgroup of subjects who did not change the chemotherapy regimen;After 12 weeks of enrollment, the assessment indicators (NRS, LANSS, EORTC QLQ-CPN20 and CTCAE grading) for overall CIPN symptoms in the subgroup of subjects who did not change the chemotherapy regimen; | — |
Countries
China
Contacts
Public ContactXiaoxiang Guan
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed