cancer related anemia,,(CRA)
Conditions
Interventions
Experimental group:On the basis of recombinant human erythropoietin (rHuEPO-a) treatment, additional oral oral adenosine monophosphate compound preparation (Su-Li-Sheng Plant Extract) was given 20ml e
Control group:Treatment with recombinant human erythropoietin (rHuEPO-a) only, with a starting dose of 150 U/kg, intravenously, 3 times/week, for 8 weeks.
Sponsors
Changzhi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Understand and voluntarily sign the Informed Consent Form (ICF); Age > = 18 years old at the time of signing the ICF, male or female; Non-myeloid malignancy confirmed by histopathological or cytology; Presence of chemotherapy-associated anemia (CRA), i.e., Hb =10 g/L after chemotherapy initiation; Plan to receive chemotherapy for at least 8 weeks after enrollment (patients can receive anti-angiogenic therapy, targeted therapy or immunotherapy at the same time as chemotherapy, etc.); Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Nutritional Risk Screening NRS 2002 score =24 weeks; Adequate hematologic and organ function [have not received the following treatments in the 2 weeks prior to blood sample collection: blood transfusions and platelet transfusions, use of drugs that promote elevated leukocytes (e.g., granulocyte macrophage colony-stimulating factor [GM-CSF] and/or long-acting granulocyte colony-stimulating factor) and erythropoietin (EPO)]; Contraception must be used by women of childbearing potential (WOCBP) and fertile men with WOCBP partners throughout the study (from the start of signing the ICF until 90 days post-dose).
Exclusion criteria
Exclusion criteria: Hypersensitivity to any component of EPO or Turbol (cAMP, etc.); Received blood transfusions, ESAs, oral or intravenous iron therapy, any blood-producing drugs, and traditional Chinese medicine and/or herbal medicine 4 weeks prior to randomization; Clinically significant anemia due to other causes (e.g., iron deficiency, vitamin B12, or folate deficiency), autoimmune anemia, hemolysis, hemorrhage, or hereditary anemia (e.g., sickle cell anemia or thalassemia); Severe infections that require antibiotic, antifungal, or antiviral therapy; History of severe cardiac disease, e.g., history of symptomatic congestive heart failure (CHF) >=2 (NCI-CTCAE 5.0), New York Heart Association (NYHA) >= Grade 2 heart failure, history of transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, etc.; Thromboembolic events (including deep vein thrombosis and pulmonary embolism) within 6 months prior to screening, but excluding interscalene thrombosis; Has uncontrolled persistent inflammatory/autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease, celiac disease, etc.); History of severe liver disease or active liver disease; Planned major surgery during treatment; Pregnant and lactating female patients; Inability to swallow, presence of intestinal obstruction, or presence of other factors affecting drug intake and absorption; Have a history of alcohol, psychotropic substance abuse and cannot abstain or have a history of mental disorder; Other conditions that may increase the risks associated with the study drug or affect trial compliance and other conditions that the investigator deems inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Blood Count; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver Function Tests;Anemia Panel; | — |
Countries
China
Contacts
Public ContactYao Jingyu
Changzhi People's Hospital
Outcome results
None listed