Evaluation of the Effects of a Mixture of Amino Acids (Amixea) on Lean Body Mass and Muscle Strengh of Patients With Unresectable Advanced Non-small Cell Lung Cancer

Most cancer patients experience weight loss at some time as their disease progresses. The resulting malnutrition increases risk of treatment complication and may lead to poor treatment response and/or tolerance, reduced quality of life and poor survival. The prevalence of malnutrition in cancer patients is thought to be as high as 80%, but reports vary with cancer location and stage, treatment history, clinical setting and assessment criteria. Weight loss with cachexia is a common presenting sign in NSCLC, representing a great concern for many patients and their families. At this regard, NSCLC cachexia is worth of particular investigation because of the prevalence of the disease, the frequency with which it is associated with weight loss and the prognostic implications of weight loss for these patients. Weight stabilization may be the most optimistic outcome to be expected in patients with cachexia and is still beneficial, as weight-losing patients with cancer cachexia who stabilize their weight have a greater quality of life and survival then those who continue to lose weight. It is, in fact, well-known that cachexia increases cancer-related mortality and has devastating effects on quality of life.Randomized controlled trial data indicate that early palliative care improves quality of life and depressive symptoms and may extend survival in advanced NSCLC compared with standard care. In particular, it has been observed that conventional nutritional supplements are not or only partly successful in inducing protein accretion in advanced cancer, suggesting an attenuated anabolic response. To prevent muscle wasting and its deleterious consequences, generating an anabolic response is crucial. Dietary essential amino acids (EAA) have anabolic properties in other wasting diseases, however data in advanced cancer are lacking. Previous studies have analyzed patients with chronic obstructive pulmonary disease with cachexia or skeletal muscle dysfunction and have demonstrated quadriceps weakness in one-third of COPD patients attending hospital respiratory outpatient services. An accurate and rapid evaluation of muscle strength which may identify patients with muscle weakness could be of crucial importance in a prompt and specific intervention in prescribing an adequate support therapy. Starting from these assumptions, the main objectives of this study are to evaluate the effects of an amino acids mixture (Amixea) on the body composition by dual-energy x-ray absorptiometry (DXA), a bone mineral densitometer, and on quadriceps maximal voluntary contraction force (QMVC) in advanced NSCLC patients, compared to placebo, after 10 weeks of treatment.