Bone marrow suppression after anti-tumor treatment for lung cancer
Conditions
Interventions
experimental group:Omega-3 intervention
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form and voluntarily participate in this study; 2.Aged 18 to 75 years, of any gender, and able to cooperate with examinations and follow-ups; 3.ECOG performance score of 0-1, with an expected survival period of >= 3 months; 4.Newly diagnosed NSCLC patients, confirmed by histology/cytology (lung adenocarcinoma or lung squamous cell carcinoma), meeting the AJCC 8th edition TNM staging (unresectable stage III, stage IV, or stage II-III resectable and planned for neoadjuvant/adjuvant therapy), and assessed by MDT as suitable for platinum-based doublet chemotherapy; 5.Lung adenocarcinoma patients with negative driver genes (EGFR/ALK/ROS1, etc.), not suitable for targeted therapy; 6.Pre-chemotherapy lipid profile shows an imbalance in the ratio of Omega-3 to Omega-6 (e.g., O-6:O-3 >= 5:1 or EPA/AA is low); 7.Have not received systemic anti-tumor treatment (chemotherapy, targeted therapy, immunotherapy) previously; 8.According to RECIST 1.1 criteria, have at least one measurable target lesion; 9.Good function of major organs: (1) Absolute neutrophil count >= 2×10^9/L, platelets >= 100×10^9/L, hemoglobin >= 120 g/L (no blood-boosting drugs or blood transfusions in the past 14 days); (2) Total bilirubin <= 1.5×ULN, ALT/AST <= 2.5×ULN (for liver metastasis <= 5×ULN), creatinine <= 1.5×ULN; (3) INR < 1.5 (no therapeutic anticoagulation in the past 14 days); 10.No history of autoimmune diseases or well-controlled, suitable for immunotherapy; 11.Have not participated in other clinical trials that may interfere with the results of this study recently.
Exclusion criteria
Exclusion criteria: 1.Those who are clearly allergic to fish oil (Omega-3 fatty acids), seafood or related additives; 2.Those with active bleeding or coagulation disorders (INR > 1.5, PLT < 50×10?/L without intervention); 3.Those with other diseases affecting the blood system (such as myelodysplastic syndrome, active systemic lupus erythematosus, etc.); 4.Those with tumor invasion of important blood vessels or with a high risk of major bleeding; 5.Those with clinical symptoms or need for drainage of pleural effusion, ascites, pericardial effusion; 6.Those currently or previously having other malignant tumors (except for fully treated basal cell carcinoma/squamous cell carcinoma of the skin, cervical carcinoma in situ, or 5 years without recurrence or metastasis after radical treatment); 7.Those who have received radiotherapy, chemotherapy, or immunotherapy within 28 days before the first administration; 8.Those who have undergone major surgery within 28 days before the first administration, or have unhealed wounds, ulcers, fractures; 9.Those with obvious gastrointestinal abnormalities affecting drug absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, post-gastrointestinal resection, etc.); 10.Those who have had active bleeding within 2 months before the first administration, or are taking anticoagulant drugs, or have a high risk of bleeding; 11.Those with positive HIV antibodies; 12.HBsAg or HBcAb positive with viral replication, or HCV-Ab positive with viral replication; 13.Presence of severe heart, liver, kidney diseases or other serious comorbidities; 14.Pregnant or lactating period or planning to get pregnant during the study period; 15.Mental or cognitive disorders, unable to cooperate with the study; 16.Autoimmune diseases not effectively controlled, and immunotherapy may aggravate the condition; 17.Other situations determined by the researcher as not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade 3 or higher bone marrow suppression (according to the CTCAE v5.0 standard) (including leukopenia or neutropenia, anemia, and thrombocytopenia).; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion and frequency of red blood cell and platelet transfusions, as well as the usage rate of G-CSF;The incidence rate of omega-3-related adverse events;Abnormal liver and kidney functions;Recovery time of bone marrow suppression;rash;Changes in inflammatory factors (CRP, IL-6, TNF-a) levels, changes in Omega-3 fatty acid levels; Changes in the proportion of neutrophils in the blood count, changes in the proportion of neutrophils.;gastrointestinal reaction; | — |
Countries
China
Contacts
Public ContactSuwenmei
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed