Pancreatic cancer
Conditions
Interventions
Impact oral group:The participants will receive dietary nutrition guidance and, in addition to their regular three meals, will start to take an oral immunonutritional supplement 500ml per day (250ml p
non-ONS group:Participants will receive dietary nutrition guidance, maintaining their regular three meals without any additional oral nutritional supplement (ONS).
Sponsors
Pancreas center, The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced or metastatic pancreatic cancer, eligible for both males and females. 2. Age between 18 and 80 years (inclusive of 18 and 80 years). 3. ECOG PS score of 0-2. 4. Weight loss of more than 5% in the last 3 months. 5. Scheduled to receive chemotherapy (including intravenous and oral chemotherapy), with no limitation on the number of chemotherapy lines. 6. Voluntarily sign a written informed consent form. 7. At least one measurable lesion (according to mRECIST1.1 criteria, the longest diameter of the tumor lesion on CT scan should be =10 mm, with a scan slice thickness not exceeding 5 mm). 8. Good function of major organs, meaning that related examination indicators meet the following requirements within 14 days before randomization: Total bilirubin = 1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) = 5×ULN; Estimated creatinine clearance = 60 ml/min (using the Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Known allergy to the ingredients or excipients of the medication used in this trial; 2. Psychiatric disorders or mental impairment, poor compliance, inability to cooperate or report treatment responses; 3. Presence of uncontrolled third-space fluid accumulation (e.g., moderate to large pleural effusion, pericardial effusion, ascites) that cannot be managed by drainage or other methods, severe edema affecting body weight assessment; asymptomatic, small amounts of pleural or ascitic fluid not requiring clinical intervention may be included after strict control; 4. BMI > 30 kg/m²; 5. Patients unable to eat orally; 6. Severe organic lesions or major organ failure, such as decompensated heart or lung failure, leading to intolerance to chemotherapy; 7. The investigator believes that the subject is unable to complete the entire trial process or has other conditions unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary intake;Basal Metabolic Rate, Fat-free mass, Skeletal muscle mass,etc;Nutrition status;Performance status; | — |
Countries
China
Contacts
Public ContactMin Tu
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed