Advanced solid tumor
Conditions
Interventions
Group A:Take the photo for 3 weeks and change to cordycepin tablet for 3 weeks
Group B:First take cordyceps tablets for 3 weeks, then change to photo for 3 weeks
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) The patient or his/her legal guardian voluntarily participates and signs the informed consent form. On the date of signing the informed consent form, men or women over the age of 65 (including the cut-off value) received more than 1 course of capecitabine monotherapy or capecitabine combination therapy, and the follow-up regimen did not change the dose to continue to treat patients with advanced solid tumors for more than 2 courses. (2) Met the criteria for carcinogenic fatigue (CRF) in the Chinese Guidelines for Clinical Practice of Diagnosis and Treatment of Cancer-related Fatigue (2021 Edition), and the score of carcinogenic fatigue on the Fatigue Level Screening Scale (Piper Fatigue Survey Scale) was =5 points. (3) Do not receive other treatments for cancer-related fatigue during the treatment period. (4) KPS = 60 points, estimated survival = 6 months: (5) Normal mental awareness, can correctly understand the content of the questionnaire, and can fill in the Piper form independently; (6) The patient's laboratory test results are consistent; Complete blood count: neutrophil = 1.0×109/L, hemoglobin = 70 g/L, platelets = 50×109/L. Liver function tests: ALT, AST = 3× ULN, and total bilirubin = 1.5× ULN. Renal function: creatinine = 1.5× ULN. Cardiac function: Left ventricular ejection fraction (LVEF) = 40 percent Coagulation: fibrinogen = 1.0 g/L, activated partial thromboplastin time (APTT)= 1.5× ULN, prothrombin time (PT) = 1.5× ULN.
Exclusion criteria
Exclusion criteria: (1) Patients with severe emaciation (BMI less than 17), severe anemia (Hb less than 60g/L), and cachexia; Those who have severe difficulty eating and are unable to take recovery tablets orally (2) Those who are positive for hepatitis B and hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood; Patients with severe hepatic insufficiency. (3) The patient has central nervous system pathology (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases). (4) Patients had uncontrollable infectious disease within 4 weeks prior to enrollment. (Genitourinary infections and upper respiratory tract infections < CTCAE grade 2, with the exception of EBV infection). positive for human immunodeficiency virus (HIV) antibodies; Those who test positive for syphilis. (5) The patient has central nervous system lesions (such as cerebral edema, requiring hormonal intervention, or progression of brain metastases). (6) Patients with uncontrollable infectious diseases and active autoimmune diseases within 4 weeks prior to enrollment. Patient has received a prophylactic live vaccine or live attenuated vaccine within 4 weeks prior to screening. (1) Patient has participated in other clinical studies within 4 weeks prior to screening. (2) Patients with a history of severe drug allergy or penicillin allergy in the past, and those who are known to be allergic to cordycepin. (3) Patient has substance abuse/addiction. (4) In the judgment of the investigator, the patient has other conditions that are not suitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Piper score Change in scale score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Piper score Change Value ;Proportion of patients with moderate fatigue;KPS change;Quality of life scale score changes;Haematological index counts;Values of serum immunomarkers and differences from baseline;Twelve cytokines and difference from baseline; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Shanghai Sixth People's Hospital
Outcome results
None listed