A Pilot Study of Amino Acids in Unresectable Non-Small-Cell Lung Cancer Patients During Chemotherapy: A Randomized Serial N-of-1 Trials Design

The aim of this study was to evaluate the effect of amino acids (AAs) on immune function and inflammation level in patients with NSCLC receiving chemotherapy. We conducted a series of randomized, multiple-crossover, double-blind, placebo-controlled N-of-1 trials comparing AAs with isocaloric glucose in unresectable NSCLC patients and combined the individual results using Bayesian statistical modeling. 25 patients completed two cycles of chemotherapy. The baseline total blood albumin (ALB) level in all patients was 28 +/- 3.3 g/l, and the mean total ALB level in patients receiving AAs supplementation and isocaloric glucose was 29.2 +/- 2.2 and 28.1 +/- 3.7 g/l, respectively (P = 0.028). Patients' baseline C-reactive protein (CRP) level was 4 +/- 1.2 mg/l, the mean total CRP level in patients receiving AAs supplementation and isocaloric glucose was 11 +/- 2.8 and 13 +/- 3.2 mg/l, respectively (P = 0.028). The baseline total blood CD4(+) T cells level was 36 +/- 7.8%. The percentage of CD4(+) T cells in patients receiving AAs supplementation and isocaloric glucose was 42 +/- 6.4 and 33.7 +/- 17.3, respectively (P = 0.034). Our preliminary results indicated that AAs improve immune status and suppress inflammation in unresectable NSCLC patients receiving chemotherapy.