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
Evaluation of the Effects of a Stoichiometric Mixture of Amino Acids (Amixea) on Lean Body Mass and Muscle Strengh of Patients With Unresectable Advanced Non-small Cell Lung Cancer: a Randomized, Double Blind, Placebo-controlled, Multicenter Study
The primary objectives of this study are to evaluate the effects of an amino acid mixture
(Amixea) on the body composition as assessed by DXA, and on QMVC as assessed by strain
gauge, in advanced NSCLC patients, compared to placebo, after 10 weeks of treatment.
Secondary objectives are to evaluate the activity of Amixea on the degree of protein
synthesis, on the nutritional risk and status and quality of life in advanced NSCLC
patients, compared to placebo, after 10 weeks of treatment. In a small subsample, body
composition will be evaluated opportunistically from clinically available CT scans.
Adherence to, and patient satisfaction of treatment will be evaluated as exploratory
objectives of this study. Finally, the overall safety and product tolerability will be
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
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
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
Cancer Patients With Cachexia
Helsinn Healthcare SA
Helsinn Healthcare SA