Immunonutrition Effects on Nutrition and Immunity in HNC During Radiotherapy

NCT07017218 | Not Yet Recruiting DMC

• 1 other identifier: IIT2025-06
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Head and neck cancer (HNC) is one of the most common types of malignant tumors, often leading to malnutrition due to its complex anatomical location near many functional organs. Radiotherapy, an essential treatment modality for HNC, can exacerbate malnutrition, potentially causing radiotherapy failure. Both domestic and international guidelines advocate early nutritional intervention for HNC patients at risk of malnutrition; however, specific recommendations on the type of nutritional treatment are lacking. Immunonutrition has shown promise in regulating the immune microenvironment, enhancing immune response, and reducing radiotherapy side effects compared to conventional nutritional interventions. However, there is a lack of studies focusing on immunonutritional therapy during the radiotherapy process for HNC in China. Therefore, this study aims to investigate the effects of immunonutrition on nutritional status, immune function, and quality of life (QoL) in head and neck cancer (HNC) patients undergoing radiotherapy. This prospective interventional study enrolled 48 head and neck cancer (HNC) patients scheduled to undergo radiotherapy (with or without concurrent chemotherapy). All participants received an immunonutrition formula supplemented with arginine, ω-3 fatty acids, and nucleotides. Throughout the radiotherapy course, certified dietitians and oncology nurses provided standardized nutritional guidance based on a five-step nutritional management protocol. Primary outcomes included:Radiotherapy-related adverse events (e.g., mucositis, dysphagia) assessed at four time points during radiotherapy (weeks 1, 3, 5, and 7) using CTCAE v4.0 criteria;Longitudinal changes in nutritional status (serum albumin, BMI), immune-related biomarkers , and quality of life were assessed at baseline, mid-radiotherapy (week 4), and post-treatment (week 7).

Conditions

Head and Neck Cancer; Nutrition

Keywords

Head and neck cancer; immunonutrition; radiation

Outcome Measures

Primary Outcomes (1)

• Severity of oral mucositis measured by CTCAE v4.0 (Grades 0-4)

  The grades of oral mucositis were measured and recorded by our professional nutritionists at four time periods during radiotherapy. The classification standard of oral mucositis was based on CTCAE v4.0 (Grade 0: asymptomatic; Grade I: Erythema appears on the oral mucosa, accompanied by pain, but it does not affect eating; Grade II: Erythema and ulcers appear on the oral mucosa, and solid food can be consumed; Grade III: Severe erythema and ulcers appear on the oral mucosa, and solid food cannot be consumed; Grade IV: Ulcers have fused into patches, with necrosis, and the patient is unable to eat)

  Assessed weekly during radiotherapy at weeks 1, 3, 5, and 7 of treatment

Secondary Outcomes (3)

• Change in body weight (kg) from baseline

  at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)

• Change in Body Mass Index (BMI, kg/m²) from baseline

  at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)

• Change in serum albumin concentration (g/dL) from baseline

  at baseline, mid-radiotherapy (week 4), and post-treatment (week 7)

Study Arms (1)

Immunonutrition

EXPERIMENTAL

Dietary Supplement: IMPACT

Interventions

IMPACT DIETARY_SUPPLEMENT

immune enhanced formula enriched in arginine, n-3 PUFA and nucleotide

Immunonutrition

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Tao Zhang, MD

CONTACT

+86 13708311156; tumorzzt@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Radiotherapy department

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: June 12, 2025
• Study Start: June 20, 2025
• Primary Completion: November 30, 2025
• Study Completion: February 28, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-05