Chemotherapy-induced peripheral neuropathy in breast cancer patients
Conditions
Interventions
Control group:Placebo was used for 24 weeks for a total of 6 months, with placebo (QD) taken once daily for the first 3 months and placebo (QOD) taken once every other day for the last 3 months.
Experimental group:A total of 24 weeks (6 months) were treated with Ruyan Chemical Poison Decoction (QD) once a day for the first 3 months and Ruyan chemical poison Decoction (QOD) once every other da
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand the purpose and requirements of the study and be able to voluntarily sign an informed consent form (ICF) to participate in the study. 2. Age =18 and 8 points (see Appendix 3- European Organization for Research and Treatment of Cancer (EORTC) -CIPN20) to ensure that symptoms are severe enough to warrant treatment, or 2) The initial Numerical Evaluation Scale (NRS) score of mean pain =4 points in the week before randomization. 5. Use the Common Terminology Standard for Adverse Events (CTCAE; V5.0) neuropathy 40IU/L and estradiol <20pg/mL to be considered postmenopausal and infertile, unless they are on hormone replacement therapy. 7.Ability to comply with study visit schedules and other programme requirements.(YNMT)·
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Overweight, defined as body mass index (BMI) >40kg/m2. 3. Any neuropathy other than CIPN is present. 4. There is a group of underlying diseases that can be used to better explain the cause of neuropathy, such as diabetes or risk factors for severe B12 deficiency (malabsorption syndrome, atrophic gastritis, vegan diet, etc.), or megaloblastic (macrored cell) anemia consistent with B12 deficiency. However, patients with mild B12 deficiency who have been successfully treated before chemotherapy and are not associated with neuropathy may participate in this study. 5. In the investigators' judgment, there are skin disorders in the affected skin area that may interfere with the evaluation of neuropathic pain symptoms. 6. The presence of non-CIPN pain that may interfere with study evaluation and/or peripheral neuropathic pain self-evaluation. 7. As determined by clinical history, there was a history of alcohol or drug/chemical abuse in the year prior to randomization. 8. Use of opioids =30mg morphine dose equivalent on 3 or more days per week in the month prior to screening. 9. Use of cannabidiol (CBD) within one month prior to screening. 10. Urine drug screening results are positive for prohibited drugs or over-the-counter controlled substances at screening. 11. Plan to change current medication or any other intervention designed to treat or relieve signs or symptoms of CIPN between screening and study completion. 12. Use implantable medical devices (e.g., spinal cord stimulators, intravaginal infusion pumps, or peripheral nerve stimulators) to treat pain. 13. For screening, heart-rate adjusted QT interval (QTcF) >460ms or >480ms on a 12-lead electrocardiogram (ECG) using the Fridericia formula (in the presence of right bundle branch block), or medications known to lengthen the QT interval (including azithromycin, chloroquine/mefloquine, clarithromycin, halperil) are required Doxorubicin, erythromycin, moxifloxacin, and sevoflurane), or a family or personal history of long QT syndrome or ventricular arrhythmias (including tip twisty ventricular tachycardia and ventricular didynia), or a history of prolonged QT intervals that cannot be attributed to an established, transient cause. 14. Any of the following abnormal laboratory test values are present: hemoglobin 1.5× upper limit of normal (ULN), or >3×ULN (in cases where Gilbert's disease is confirmed). 17. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values > 2.0×ULN. 18. Human immunodeficiency virus (HIV) infection, acute hepatitis A or active hepatitis virus (hepatitis B or C) infection. In addition to HCV antibody (HCV-AB) positive and HCV RNA quantitative negative, other HCV-AB positive, human immunodeficiency virus (HIV) positive, hepatitis A virus antibody (anti-HAV IgM) positive; HBV screening includes Hepatitis B Surface antigen (HBsAg), Hepatitis B Surface Antibody (HBsAb), and Hepatitis B core antibody (HBcAb) : HBV DNA testing is required for positive HBsAg and/or HBcAb, and screening fails if HBV DNA is positive. 19. Prothrombin time/International Normalized ratio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (TEAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate of CIPN;Changes in the impact of neuropathic signs and symptoms on function compared to baseline;Effect of neuropathic signs and symptoms on function (for pain and sensory assessments) from baseline;Pain changes from baseline; | — |
Countries
China
Contacts
Public ContactSuiwen Ye
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed