Chemotherapy - Induced Peripheral Neuropathy(CIPN)
Conditions
Interventions
The experimental group:Yangxue Rongjin Pills + Mecobalamin Tablets
The control group:Simulant of Yangxue Rongjin Pills + Mecobalamin Tablets
Sponsors
Beijing Hospital of TCM Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Subjects received a combination chemotherapy regimen containing oxaliplatin and this chemotherapy was the cause of CIPN. (2) TCM syndrome differentiation belongs to qi deficiency and blood stasis collaterals obstruction syndrome; (3) Age 18-70 years old (including endpoints); (4) After the end of the chemotherapy course CIPN appears and satisfies 4 weeks = CIPN symptom duration = 24 weeks; (5) "WHO Chemotherapy Peripheral Neurotoxicity" was graded as grade 1 to 3; (6) The expected survival period is = 12 months. (7) Patients voluntarily participated in the study signed informed consent forms and were able to comply with the visit and related procedures stipulated in the protocol.
Exclusion criteria
Exclusion criteria: (1) Those who have already developed peripheral neuropathy due to other reasons (such as radiation or malignant plexus disease lumbar or cervical radiculopathy vitamin B12 deficiency or diabetes) before chemotherapy or those whose clinical manifestations of tumor syndrome are primary peripheral nerve damage. (2) Hyponatremia hypokalemia hyperchloroacidosis adrenal failure and adrenal cortical hypofunction (Addison's disease) hepatic coma diabetes cerebral or leptomeningeal or bone metastases due to hepatic and renal insufficiency; (3) Laboratory test values within 7 days before enrollment meet the following criteria:blood routine: neutrophil count (ANC) 1.5 times the upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN);Renal function: creatinine clearance (CCr) 7.5%; (4) Patients who have received neurotoxic chemotherapy with oxaliplatin as a non-first-line chemotherapy agent before or in the past and who have systematically received any other drug specifically designed to treat or prevent neuropathy; (5) Patients who have received systematic acupuncture cupping massage and other traditional Chinese medicine therapies due to neurotoxicity or lesions before or in the past; (6) An anxiety or depression score of = 11 was measured by the Hospital Anxiety and Depression Scale; (7) Concurrently participating in other interventional clinical studies (unless participating in observational studies or in the follow-up phase of interventional studies); (8) Have a history of alcohol dependence or drug abuse; (9) Those who are allergic to the constitution or are allergic to Yangxue Rongjin Pills Yangxue Rongjin Pills placebo and methylcobalamin tablets; (10) Concurrently taking drugs with similar efficacy to Yangxue Rongjin Pills and cannot be discontinued after enrollment (refer to Annex 9); (11) Have taken a banned medication within two weeks; (12) Women of childbearing age are pregnant or breastfeeding have a family plan within six months have a positive pregnancy test (urine HCG or blood HCG) or cannot use effective contraception during the test; (13) Other circumstances considered inappropriate by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EORTC QLQ-CIPN20; | — |
Secondary
| Measure | Time frame |
|---|---|
| CIPN significant remission time;TCM Quality of Life Assessment Scale (CQ-D11);TCM Syndrome Score Scale;FACT/GOG-Ntx Neurotoxicity Assessment Tool Scale;Total Neuropathy Score (TNS);Numerical Rating Scale (NRS);EORTC QLQ-CIPN20; | — |
Countries
China
Contacts
Public ContactGuowang Yang
Beijing Hospital of TCM Capital Medical University
Outcome results
None listed