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Background: Patients with head and neck cancer (HNC) undergoing concurrent chemoradiotherapy (CCRT) are at high risk for dysphagia, malnutrition, and immunosuppression. Accordingly, arginine, glutamine, and Omega-3 fatty acidsare immuneenhanced nutrition can promote cellular immunity. We aimed to examine the impact of immunonutrition diet on nutritional status, in addition to CCRT toxicities, within this group of patients. Methods: Forty patients with HNC who were treated with curative CCRT were randomized into group A (n = 20), patients who received a regular diet and dietary counseling by a protocol dietician, and group B (n = 20), patients who received a regular diet plus immuneenhanced nutrition supplements and dietary counseling by the same protocol dietician. Outcome measures were weight loss, protein and energy intake, serum pre-albumin and albumin, and toxicities of CCRT were evaluated at baseline, weekly and at the end of treatment. Results: Both groups were well balanced at baseline. One patient from group A (1/20) withdrew consent. Seven patients from group B (7/20) withdrew from the study; 1 patient could not tolerate the side effect of chemotherapy and 6 patients could not tolerate the taste of oral immune-enhanced nutrition. A significant loss in total body weight was observed in group A patients (p<0.001), whereas in group B there no significant weight loss (p=0.109). Median percentage change from baseline of energy intake was 19.6%, and 22.9% at the end of treatment for group A and B respectively. The circulating levels of nutritional markers, pre-albumin and albumin, decreased after CCRT in both groups. There was a significantly decreased level of albumin in group A compared to that of group B, at the end of treatment. During CCRT; 4 patients (20%) in group A and 1 patient (5%) in group B developed grade 3 mucositis, respectively. One patient (5%) in group A had grade 3 radiation dermatitis. Grade 3-4 hematologic toxicities, mainly in absolute neutrophil count (ANC), were significantly higher in group A than group B: 20% versus 0% (p=0.035). Over the 7-week period of CCRT, both the intention to treat analysis and per protocol analysis revealed similar results in scaled for all endpoints. Conclusions: Nutritional counseling and immuno-nutrition can reduce the deterioration of nutrition status and also significantly reduced hematologic and non-hematologic toxicity of CCRT in head and neck cancer. [ABSTRACT FROM AUTHOR]