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 of dysphagia, malnutrition, and immunosuppression.  Arginine, glutamine, and Omega-3 fatty acidsare immune-enhanced nutrition that can promote cellular immunity.We aimed to examine the impact of immunonutrition diet on nutritional status, and CCRT toxicities, in this group of patients.

Methods: Forty patients with HNC who treated with curative CCRT were randomized to: group A (n = 20), patients who received a regular diet and dietary counselingby a protocol dietician; 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 not significant loss in group B (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 more than 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 significant higher in group A than group B; 20% versus 0% (p=0.035).Over the 7-week period of CCRT, both intention to treat analysis and per protocol analysis revealed similar 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.

Keywords : immune-enhanced nutrition, concurrent chemoradiotherapy, head and neck cancer