A prospective, randomized blank controlled, multi-center clinical study of Shenmai injection in the treatment of cancer-induced fatigue

Tianjin Cancer Hospital0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•1. Patients diagnosed with malignant tumors by pathology or cytology (if the patient is undergoing disease treatment, such as chemotherapy, targeted therapy, immunotherapy or radiation therapy, the patient must have completed >= 1 cycle of treatment); the recommended chemotherapy regimens are commonly used first- and second-line regimens, such as pemetrexed/docetaxel/paclitaxel combined with platinum for non-small cell lung cancer, CAPEOX, FOLFOX, FOLFIRI, etc.
•2. Aged 18-75 years, gender is not limited;
•3. Expected survival period >= 3 months;
•4. Laboratory test values must meet: hemoglobin (HGB) >= 100g/L (patients should not have a history of blood transfusion within 30 days); creatinine <= 1.2 times the upper limit of normal; alanine aminotransferase <=1.5 times the upper limit of normal; aspartate aminotransferase <=1.5 times the upper limit of normal;
•5. Non-breastfeeding patients;
•6. Patients diagnosed with cancer-related fatigue by ICD-10 and FACT-F fatigue scale;
•7. Have a clear mind, can communicate normally, and can cooperate with medical staff to complete questionnaires and physical examinations and assessments;
•8. Voluntarily join the study and sign the informed consent.

•1. Participating in other clinical trial investigators;
•2. Patients with multiple organ failure;
•3. Known to be allergic, highly sensitive or intolerable to the research-related drugs or their excipients;
•4. Are using other drugs or non-drug interventions for fatigue (including but not limited to stimulants, antidepressant therapy, acupuncture, traditional Chinese medicine, etc.);
•5. Combined with other diseases that may cause fatigue: such as muscular dystrophy, muscle weakness caused by uncontrolled endocrine, metabolic diseases or neurological diseases;
•6. Those who use steroids systemically due to chronic skin rashes, autoimmune diseases, etc. (regular doses of dexamethasone are allowed for antiemetic and other treatments);
•7. Pregnant patients or patients of childbearing age (including men) who are unwilling to take contraceptive measures;
•8. Patients with symptomatic and uncontrollable neurological, psychiatric diseases or mental disorders;
•9. Major surgery, including general anesthesia surgery, within 4 weeks before enrollment;
•10. Any circumstances that the investigator believes that participating in the trial is not in the best interests of the subjects (such as endangering their health) or that will hinder the evaluation of the trial protocol.

发起方

Tianjin Cancer Hospital