nasopharyngeal carcinoma
Conditions
Interventions
Test group:The patient underwent 2-3 cycles of induced chemotherapy with GP regimen and then entered synchronous radiotherapy and chemotherapy. Oral immunonutrient therapy (Su Yi Su) was administered
Control group:The patient underwent 2-3 cycles of GP regimen induced chemotherapy and then entered synchronous radiotherapy and chemotherapy. Oral isocaloric standard nutrient (Ansu) was administered
Sponsors
the First Afliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Age 18-70 years old, male or non-pregnant women; Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated,WHO type II or III). newly diagnosed stage III-IVa (8th AJCC/UICC stage) NPC patients; The levels of major organ function meet the following criteria: (1)Hematology: WBC >= 3.0 × 10^9/L, ANC >= 1.5 × 10^9/L, PLT >= 100 × 10^9/L, HGB >= 90 g/L; (2) Liver function: ALT, AST= 60 ml/min (calculated using the Cockcroft-Gault equation); (4) Adequate coagulation function: defined as an international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times the ULN; (5) Normal levels of cardiac enzymes; 6. The patient has signed informed consent forms and is able to comply with the study's planned visits, treatment plans, and laboratory tests.
Exclusion criteria
Exclusion criteria: 1.Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 2.Age 18-70 years old, male or non-pregnant women; 3.Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated,WHO type II or III). 4.newly diagnosed stage III-IVa (8th AJCC/UICC stage) NPC patients; 5.The levels of major organ function meet the following criteria: (1)Hematology: WBC >= 3.0 × 10^9/L, ANC >= 1.5 × 10^9/L, PLT >= 100 × 10^9/L, HGB >= 90 g/L; (2) Liver function: ALT, AST= 60 ml/min (calculated using the Cockcroft-Gault equation); (4) Adequate coagulation function: defined as an international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times the ULN; (5) Normal levels of cardiac enzymes; 6. The patient has signed informed consent forms and is able to comply with the study's planned visits, treatment plans, and laboratory tests. Exclusion Criteria: 1. History of investigational Oral Impact®/ENSURE® use within the month prior to enrollment; 2. Known allergy or intolerance to any component of investigational Oral Impact®/ENSURE® or related chemotherapy drugs; 3. Poor glycemic control in patients with diabetes; 4. Patients with autoimmune diseases; 5. Patients with active infections; 6. Patients who have received radiation therapy or other anti-tumor treatments in the past; 7. Patients with a history of other malignant tumors; 8. Presence of oral mucositis at baseline; 9. Malnutrition at baseline; 10. Patients who cannot eat the required amount of food at baseline and require parenteral or enteral nutrition; 11. Inability to eat soft solid foods at baseline; 12. History of human immunodeficiency virus (HIV) or active hepatitis B/C virus infection; 13. Participation in other intervention clinical studies within one month; 14. Subjects deemed by the investigator to have other factors that may force them to terminate the study, such as having other serious illnesses (including mental illnesses) that require concomitant treatment, significantly abnormal laboratory test results, or family or social factors that may affect subject safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of severe oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| the latency period of severe oral mucositis;The duration period of severe oral mucositis;Inflammatory status;Immune status ;Nutritional status;Quality of life;Objective response rate;Overall Survival(OS);Progress-free survival(PFS);locoregional recurrence-free survival (LRRFS);distant metastasis-free survival (DMFS);acute and late adverse events (AEs) ; | — |
Countries
China
Contacts
Public ContactMin Kang
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed