Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT07017218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunonutrition Effects on Nutrition and Immunity in HNC During Radiotherapy
Sponsor:
First Affiliated Hospital of Chongqing Medical University
Organization:
Study Overview
Official Title:
The Impact of Immune Nutrition on Nutritional and Immune Status of Head and Neck Cancer Patients During Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: