Randomized study of nutritional status and treatment toxicities of oral arginine, glutamine, and Omega-3 fatty acids during concurrent chemoradiotherapy for head and neck cancer patients

Abstract

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 immune-enhanced 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 immune-enhanced 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.