Evaluation of the Effects of a Mixture of Amino Acids (Amixea) on Lean Body Mass and Muscle Stren… (NCT02877966) | Clinical Trial Compass
WithdrawnNot Applicable
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
Stopped: Change of Trial Sponsor
Australia0Started 2016-10
Plain-language summary
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.
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Females and males at least 18 years of age.
✓. Stage III or IV unresectable NSCLC (documented histologic or cytologic diagnosis according to AJCC Cancer Staging).
✓. On or planned first line chemotherapy or targeted therapies.
✓. ECOG performance status ≤ 2.
✓. Estimated life expectancy of \> 6 months at the time of screening.
✓. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤5 x upper limit of normal (ULN).
✓. Adequate renal function, defined as creatinine ≤2 x ULN, or calculated creatinine clearance \>30 ml/minute.
✓. Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.
Exclusion criteria
✕. Other forms of lung cancer (eg, small cell, mesothelioma)
What they're measuring
1
effects of an amino acid mixture (Amixea) on the body composition
✕. Known HIV, hepatitis (B \& C), or active tuberculosis
✕. Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patients must be well recovered from acute effects of surgery prior to screening. Patients should not have plans to undergo major surgical procedures during the treatment period.
✕. Patients unable to readily swallow. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded.