Nasopharyngeal cancer
Conditions
Interventions
Placebo group:Standard treatment + placebo was taken orally for 21 consecutive days, and a blood routine was drawn before and after and during the treatment
Formula granule group:Standard treatment + formula granules were taken orally for 21 days, and blood routine was drawn before and after and during the treatment
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) All patients have been histologically or cytologically confirmed to have solid tumors (such as lung cancer, breast cancer, malignant lymphoma, colon cancer, etc.), and have received a standardized chemotherapy regimen for at least one cycle, with thrombocytopenia occurring after chemotherapy; the minimum PLT value during the screening period is <100×10^9/L, and the maximum PLT count after recovery is <=300×10^9/L; (2) Age between 18 and 75 years old, regardless of sex; (3) Clear consciousness, without cognitive or communication barriers; (4) The investigator assesses the expected survival time to be no less than 3 months; (5) Able to follow a semi-liquid diet or higher standard; (6) According to the Eastern Cooperative Oncology Group (ECOG) performance status grading, PS status of 0-2 points; (7) All patients maintain the same chemotherapy regimen and dosage during the trial (dose adjustment not exceeding ±10%), with serum urea nitrogen, creatinine, transaminases, and bilirubin <=1.5 times the upper limit of normal values. The aforementioned clinical trial protocol and patient informed consent form have been approved by the ethics committee of the hospital conducting the clinical trial, and patients enter the screening phase after signing the written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with critical conditions who have undergone major surgical operations or suffered severe traumatic injuries within the past 30 days, combined with serious organic diseases or important organ failures (such as decompensated heart, lung, liver, or renal failure); (2) Pregnant or breastfeeding women, or women of childbearing age with a positive urine pregnancy test; male and female subjects who have not taken effective contraceptive measures, or those planning to conceive during the trial period; (3) Patients with an expected survival time of less than 3 months; (4) Patients with mental disorders; (5) Patients with poor compliance who do not follow the trial requirements for treatment and observation; (6) Patients under 18 years of age or over 76 years of age; (7) Individuals with a documented allergy history to any component of the trial product; (8) Patients with intestinal obstruction who cannot take oral medications, those suffering from severe malabsorption or other diseases affecting gastrointestinal absorption; (9) Individuals deemed unsuitable to participate in this study by the investigator; (10) Participation in other drug clinical trials within 30 days prior to screening; (11) Patients who need to take Chinese medicine to increase platelet counts besides the trial product during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet count;Mean time to platelet recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients transfused with platelets;Combined use of recombinant human thrombopoietin and/or interleukin-11 counts; | — |
Countries
China
Contacts
Public ContactZhang Bei
Sun Yat-sen University Cancer Center
Outcome results
None listed