Immunonutrition Effects on Nutrition and Immunity in HNC During Radiotherapy

Launched by FIRST AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special type of nutrition, called immunonutrition, on patients with head and neck cancer (HNC) who are undergoing radiotherapy. The goal is to see if this nutritional support can improve patients' overall nutrition, boost their immune system, and enhance their quality of life while they receive treatment. The study will involve 48 patients aged between 18 and 75 who are confirmed to have head and neck cancer and are scheduled for radiotherapy, with or without chemotherapy. To be eligible, patients should not be severely malnourished and must meet certain health criteria.

Participants in the trial will receive a special nutritional formula that includes ingredients thought to help with healing and immune response, such as arginine and omega-3 fatty acids. Throughout the treatment, trained dietitians and nurses will provide guidance on nutrition to ensure participants are supported. The researchers will monitor participants for any side effects from the radiotherapy and track changes in their nutritional status, immune function, and quality of life at different points during the treatment. This study is important because it aims to provide better nutritional strategies for patients with HNC, which can help improve their treatment outcomes and overall well-being.

Gender

ALL

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