chemotherapy induced thrombocytopenia
Conditions
Interventions
Formula granules group:Oral administration "Ziyuanling" formula granules
Decoction pieces group:Oral administration "Ziyuanling" decoction pieces
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) All patients were confirmed by histology or cytology to have solid tumors (such as lung cancer, breast cancer, malignant lymphoma, colon cancer, etc.), and had received more than one cycle of standard chemotherapy, and patients with thrombocytopenia after chemotherapy; The minimum PLT value for the screening cycle is<100 × 109 pieces/L, and the maximum PLT count after recovery is = 300 × 109 pieces/L. (2) 18 years old = Age = 75 years old, gender unlimited; (3) Clear awareness, no cognitive or communication barriers; (4) The expected survival time is determined by the researcher to be no less than 3 months; (5) Those who can enter a standard diet of semi liquid or above; (6) According to the physical fitness criteria of the Eastern Cooperative Oncology Group (ECOG) in the United States, the PS status is scored 0-2 points; (7) All patients maintained the same chemotherapy regimen and dosage during the trial period (dose adjustment not exceeding ± 10%), with serum urea nitrogen, creatinine, transaminase, and bilirubin = 1.5 times the upper limit of normal values.
Exclusion criteria
Exclusion criteria: (1) Screening critically ill patients who have undergone major surgical procedures or severe traumatic damage within the first 30 days, combined with severe organic lesions or important organ failure (such as decompensated heart, lung, liver, kidney failure); (2) Pregnant or lactating women, or women of childbearing age who have a positive urine pregnancy test; Male and female participants who have not taken effective contraceptive measures or plan to conceive during the trial period; (3) Patients with an expected survival period of less than 3 months; (4) Patients with mental disorders; (5) Those who do not have strong compliance and do not follow the experimental requirements for treatment and observation of their condition; (6) Patients under 18 years old or over 76 years old; (7) Individuals with a clear history of allergies to any component of the test product; (8) Having developed intestinal obstruction that cannot be treated with oral medication, suffering from severe malabsorption or other diseases that affect gastrointestinal absorption; (9) Researchers consider it inappropriate to participate in this study; (10) Participated in clinical trials of other drugs within 30 days prior to screening; (11) Patients who need to take platelet enhancing traditional Chinese medicine other than the experimental product during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum platelet count;Duration of thrombocytopenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference between the lowest and highest values of thrombocytopenia after chemotherapy;The proportion, infusion frequency, and infusion volume of patients receiving platelet infusion;Quantity of recombinant human thrombopoietin and/or interleukin-11 used;Rate of chemotherapy completion;The time for platelets to recover to 50 x 109/L and 75 x 109/L or more; | — |
Countries
China
Contacts
Public ContactBei Zhang
Sun Yat-sen University Cancer Center
Outcome results
None listed