Malignant Bone and Soft Tissue Tumors
Conditions
Interventions
Children and Adolescents with Malignant Bone and Soft Tissue Tumors:None
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
7 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Participants and their guardians voluntarily participate in the study, sign written informed consent, have good compliance, and cooperate with follow-ups; 2. Aged 7-18 years (inclusive), with no gender limitation; 3. Patients diagnosed with malignant bone and soft tissue tumors through pathological histology and/or cytology, and planned to receive eight or more cycles of moderately to highly emetogenic chemotherapy consecutively; 4. Patients who are undergoing chemotherapy for the first time, or the interval between this chemotherapy and the previous one is six months or more; 5. No contraindications for chemotherapy in routine blood tests, liver and kidney function tests, and electrocardiograms (ECGs) before chemotherapy, and the estimated survival time is more than six months; (1) Routine blood tests should meet the following criteria (no blood transfusion in the past 14 days): 1) Hemoglobin (HB) >=90 g/L; 2) Absolute neutrophil count (ANC) >=1.5×10^9/L; 3) Platelet (PLT) >=80×10^9/L; (2) Biochemical tests should meet the following criteria: 1) Bilirubin (BIL) = 50 ml/min (Cockcroft-Gault formula); 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Exclusion criteria
Exclusion criteria: 1. The presence of other causes that may lead to nausea and vomiting in patients apart from chemotherapy (including intestinal obstruction, vestibular dysfunction, electrolyte disturbance, uremia, use of opioid analgesics, liver dysfunction, gastrointestinal diseases, and psychological factors); 2. Known uncontrolled or symptomatic active central nervous system (CNS) metastasis; 3. Patients with a history of psychotropic drug abuse that cannot be discontinued or those with mental disorders; 4. Patients who are currently receiving treatment for anxiety or depression; 5. Patients who are allergic to 5-HT3 receptor antagonists, dexamethasone, and NK-1 receptor antagonists; 6. Patients who have received total-body irradiation or radiotherapy to the upper abdomen, head, craniovertebral region, or pelvis within one week prior to enrollment; 7. Any other factors that the investigator considers may affect the treatment and measurement of this study; 8. Patients and their guardians are unable to cooperate in completing psychological scale assessments and chemotherapy diaries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anxiety;derpression;Vomiting;Nausea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life;Relative Dose Intensity;Two-Year Overall Survival Rate;Blood Biomarkers; | — |
Countries
China
Contacts
Public ContactCheng Yang, Jianru Xiao
Shanghai Changzheng Hospital
Outcome results
None listed