← Back to all trials
Not Yet Recruiting
NCT05598229
Application of Douyin in Perioperative Period of Malignant Tumor Patients
Conditions: Malignant Tumor of Bone, Perioperative Period
Sex: All
Ages: 10 Years – 70 Years
Phase: NA
Enrollment: 90
Sponsor: Henan Cancer Hospital
Summary
Fitting into the group of 90 cases of this study was to henan tumor hospital bone prosthesis replacement of surgical treatment of bone malignant tumors patients, evaluate watch trill to be bone prosthesis replacement surgery treatment of malignant bone tumor patients perioperative anxiety, depression, pain, explore watch trill to bone prosthesis replacement surgery treatment of malignant bone tumor patients of postoperative complications.
Eligibility Criteria
Inclusion Criteria:Men and women aged 10-70.
The Eastern Collaborative Oncology Group (ECOG) physical status score was 0-1.
Subjects with amputation can be relaxed up to 2 points.Pathological diagnosis of malignant tumor.
Patients undergoing bone prosthesis replacement for bone tumors.
All acute toxicities due to previous antitumor therapy or surgery resolved to grade 0-1 (according to NCI-CTCAE version 5.0) or to enrollment/exclusion criteria by day 1 of the first cycle (C1D1), except for toxicities such as hair loss that the investigator considered to pose no safety risk to the subject).Adequate organ and bone marrow function, as defined below:Blood routine (no blood transfusion, no G-CSF, no medication correction within 7 days before screening) :Neutrophil count (ANC)≥1,500/mm3(1.5×109/L);
Platelet count (PLT)≥100,000/mm3(100×109/L); Hemoglobin (Hb)≥9g/dL(90g/L);Blood biochemical:Serum creatinine (Cr)≤1.5×
upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula)≥60ml/min; Total bilirubin (TBIL)≤1.5×ULN;
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤2.5×ULN, and subjects with liver metastases should ≤5×ULN;Blood coagulation function:International normalized ratio (INR)≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5×ULN;
With my consent and signed informed consent, I am willing and able to comply with the planned visit, study treatment, laboratory tests and other test procedures.Exclusion Criteria:Received the following treatment within 14 days before C1D1:Radiotherapy, chemotherapy, immune or molecularly targeted therapy for tumors.
Some other investigational drugs.
Surgery for other sites and/or radiotherapy were planned during the study period (24 hours before surgery to 7 days after surgery).Imaging diagnosis showed the presence of central nervous system tumor lesions.
The presence of active heart disease in the 6 months before C1D1, including myocardial infarction, severe/unstable angina pectoris, etc. Poorly controlled arrhythmias with left ventricular ejection fraction <50% on echocardiography (including QTcF interval >450ms in men and >470ms in women).In the judgment of the investigator, there are concomitant diseases (such as severe diabetes, neurological or psychiatric diseases) or any other conditions that seriously endanger the safety of the subjects, may confuse the results of the study, or affect the completion of the study.
Source: ClinicalTrials.gov (NCT05598229). StuddyBuddy aggregates publicly available trial information.