An interventional study of Amixea and Placebo in Cancer Patients With Cachexia, sponsored by Helsinn Healthcare SA. Withdrawn at 3 sites in Australia. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-20.
Sponsored by Helsinn Healthcare SA · Not applicable, Interventional, and Supportive care
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 evaluated.
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.
328 studies on the registry are indexed under Cachexia; 73 are open to participants now.
Browse Cachexia studies →Helsinn Healthcare SA is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
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Exclusion Criteria:
Use of other investigational drug(s) within 30 days before study entry or during the study.
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Amixea- patented stoechiometrical mixture of EAA \& AA
Dietary Supplement: Amixea
Placebo
Other: Placebo
Amixea is a mixture of amino acids. It consists mainly of essential amino acids (EAA) that cannot be synthesized de novo by the organism, and therefore must be supplied in its diet.
effects of an amino acid mixture (Amixea) on the body composition
Lean Body Mass determination with DXA scan and Maximal Voluntary Contraction Force using dynamometer (strain gauge)
Time frame: 10 weeks of treatment
to evaluate the nutritional risk and status and quality of life in advanced NSCLC patients
Nutritional status and risk using the scored Patient-Generated Subjective Global Assessment (PG-SGA) tool
Time frame: 10 weeks of treatment
overall safety and product tolerability
Number and typology of adverse events (AEs), Physical examination and vital signs, Product tolerability
Time frame: 10 weeks of treatment
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Helsinn Healthcare SA