Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT07017218
Eligibility Criteria:
Inclusion Criteria:
* Patients must be histologically or cytologically confirmed to have head and neck cancer (HNC).
* Scheduled for radiotherapy with or without concurrent chemotherapy.
* Willingness to sign informed consent voluntarily.
* Aged between 18 and 75 years old.
* Karnofsky Performance Status (KPS) score ≥70.
* Hematological and biochemical parameters within the following ranges:
* White blood cell count (WBC) ≥3.5×10\^9/L
* Hemoglobin (Hb) ≥90 g/L
* Platelet count (PLT) ≥100×10\^9/L
* Serum albumin (ALB) ≥30 g/L
* Total bilirubin ≤1.5 times the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 - times ULN
* Life expectancy of at least 6 months.
* No severe malnutrition at baseline (e.g., body mass index \[BMI\] \>18.5 kg/m²).
Exclusion Criteria:
* Prior history of radiation therapy or biological therapy targeting the head and neck region.
* History of other malignant tumors in the past 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.
* Severe systemic diseases, such as uncontrolled diabetes mellitus, severe cardiovascular disease, or chronic renal failure.
* Pregnancy or lactation.
* Drug or alcohol abuse.
* Participation in other clinical trials within the last 3 months.
* Known allergies or contraindications to the nutritional formulations used in this study.
* Mental disorders or cognitive impairments that may affect compliance with the study protocol.
* Inability to tolerate oral nutritional supplements (ONS).
* Any condition deemed by the investigator to potentially interfere with the study objectives or participant safety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07017218
Study Brief:
Protocol Section:
NCT07017218