3594 - Immunonutrition for Prevention of Radiotherapy-Induced Severe Oral Mucositis in Head and Neck Cancer: Clinical and Cost-Effectiveness Analysis

Purpose/Objective(s):

Severe oral mucositis (SOM) remains a frequent toxicity of radiotherapy in patients with head and neck cancer, often resulting in treatment interruption, increased supportive care use, and higher health care costs. Evidence regarding the value of immunonutrition as a preventive strategy remains limited.

Materials/Methods:

This prospective, randomized, phase II trial enrolled 80 patients with head and neck malignancies undergoing definitive radiotherapy with or without concurrent chemotherapy. Patients were randomly assigned to receive immunonutrition plus standard care (n=43) or standard care with routine nutritional counseling alone(n=37). Immunonutrition was administered daily from the start of radiotherapy to 1 month after completion. The primary endpoint was the incidence of grade =3 oral mucositis. Secondary endpoints included time to onset and duration of SOM, radiotherapy interruption, nutritional and health-related quality of life measured by EQ-5D. A cost-effectiveness analysis was performed from the health care system perspective, and the incremental cost-effectiveness ratio (ICER) was calculated.

Results: Grade =3 oral mucositis occurred in 32.6% of patients in the immunonutrition group compared with 64.9% in the control group (P=0.004). Immunonutrition delayed the onset(NE vs. 29,P=0.002)and reduced the duration of SOM(8.70±16.032 vs. 29.08±26.711,P<0.001) and was associated with non-significant but fewer radiotherapy interruptions(14.0% vs.32.4%,P=0.088). Patients receiving immunonutrition demonstrated improved preservation of weight(-2.70±4.05 vs. -7.26±7.95,P=0.011) and lower inflammatory burden(IL-6,28 days during radiotherapy,10.800±11.657 vs. 17.304±21.828,P=0.035). Although immunonutrition increased direct intervention costs, reductions in SOM-related management costs and gains in health utility resulted in a favorable ICER that was below the predefined willingness-to-pay threshold(Three times the per capita GDP of China in 2024,3×13445 USD).

Conclusion: In patients with head and neck cancer receiving radiotherapy, immunonutrition reduced the incidence of severe oral mucositis and improved treatment tolerance. From a value-based perspective, immunonutrition provided additional health benefits at an acceptable incremental cost, supporting its role as a supportive care intervention during radiotherapy.

		Treatment	Control	P
Per-patient cost,Mean(SD),USD	Costs Associated with Unplanned Admissions	329.26(809.87)	409.09(749.13)	0.074
	Treatment Costs for Oral Mucositis	43.31(100.86)	49.45(84.98)	0.103
	Cost of Drug Therapy	705.14(358.29)	0	<0.001
	Total	1077.7(815.8)	458.55(743.77)	<0.001
Per patient incremental cost,USD		619.15
Per patient QALY(Mean/SD)		0.1772(0.0209)	0.1539(0.0271)	<0.001
Per patient incremental QALY		0.0233
ICER(USD/QALY)		26573.12