Head and neck malignant tumor
Conditions
Interventions
Test group:The patient received the daily oral immunonutrient, 2 bottles a day and continued until the end of radiotherapy for one month, while also providing nutrition and oral hygiene guidance.
Control group:During the treatment, the patient will eat freely and provide nutrition and oral hygiene guidance.
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) age 18 to 70 years old, gender not limited; (2) to study has fully understand and voluntarily signed the informed consent, to comply with the study period of plan and finish all the test procedures; (3) Radiotherapy to the head and neck (the total dose was about 70Gy); (4) in the Eastern United States within the tumor (Eastern Cooperative Oncology Group, ECOG) score 0-1 minute, expected survival time is more than 6 months; (5) The vital organ function could withstand the risk of treatment according to the assessment of attending physicians and researchers, and blood routine: ANC=1.5×109/L; PLT=80×109/L; Hb=90 g/L; Blood biochemistry: TBIL=1.5×ULN; ALT and AST=2×ULN; BUN and Cr=1.5×ULN and creatinine clearance =50mL/min (Cockcroft-Gault formula); (6) age female subjects, male subjects and male subjects partner agrees to use reliable contraceptive measures during the study period (e.g., abstinence, sterilization, birth control pills or other contraceptive measures, etc.).
Exclusion criteria
Exclusion criteria: (1) patients with other primary tumors or brain metastases; (2) patients with hematological diseases such as essential thrombocythemia, agranulocytosis, aplastic anemia, myelodysplastic syndrome, etc.; (3) with the rest of the site infection caused by high white blood cells and neutrophils in patients; (4) patients with severe cardiovascular and cerebrovascular diseases or liver and kidney diseases; History of chronic oral ulcers and other chronic oral diseases; (5) patients with serious concomitant diseases, including medical diseases that are not controlled and stable after treatment, or a history of neurological or psychiatric diseases (such as dementia or epilepsy), should not receive radiotherapy; (6) malignant pleural effusion or malignant peritoneal effusion or accompanied by intestinal obstruction; (7) pregnant or lactating women; (8) is expected in this study period in patients undergoing major surgery; (9) nearly 1 year has a history of alcoholism, drug addiction or drug abuse; (10) previous enteral or parenteral nutrition or allergy to any component of immune nutrients; (11) Subjects who were deemed by the investigator to be unfit to participate for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade 3 and 4 oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| the latency period of severe oral mucositis;The duration period of severe oral mucositis;Weight;Changes in nutrition-related indicators;Inflammatory change related indicators;Changes in immune-related indicators;Treatment of continuity;The number of unplanned hospitalizations was timely and prolonged; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The First Affiliated Hospital of China Medical University
Outcome results
None listed