Application of Douyin in Patients With Bone and Soft Tissue Malignant Tumors During Perichemotherapy

Launched by HENAN CANCER HOSPITAL · Oct 26, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how watching TikTok videos might help reduce feelings of anxiety and depression in patients with bone and soft tissue cancers who are about to undergo chemotherapy. Researchers will study 90 patients at Henan Cancer Hospital, dividing them into two groups: one group will watch TikTok videos, while the other will not. The goal is to see if watching these videos can make a difference in how patients feel before, during, and after their chemotherapy treatments, as well as to check if it affects any complications related to chemotherapy.

To be eligible for this trial, patients should be aged 10 to 70 years and have a diagnosed bone or soft tissue malignancy. They must have had at least one previous chemotherapy treatment and be planning to start a new round. Patients should also be in relatively good health, meaning they don't have serious ongoing health issues and their blood counts are within certain limits. Participants will need to commit to the study procedures, and they will be monitored closely throughout the trial to ensure their safety.

Gender

ALL

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 bone and soft tissue malignancy. Patients who have received at least one previous chemotherapy and are planning to receive new chemotherapy.
• • All acute toxicities from previous antitumor therapy or surgery resolved to grade 0-1 (according to NCI-CTCAE, version 4.03) or to enrollment/exclusion criteria by day 1 of the first cycle (C1D1), with the exception of 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 7 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 chemotherapy and 7 days after chemotherapy).
• • 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.