Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change of Trial Sponsor
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients With Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amixea | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Amixea- patented stoechiometrical mixture of EAA \& AA
- interventionNames
- Dietary Supplement: Amixea
- type
- PLACEBO_COMPARATOR
- label
- Arm B
- description
- Placebo
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- effects of an amino acid mixture (Amixea) on the body composition
- timeFrame
- 10 weeks of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria:
1. Females and males at least 18 years of age.
2. Stage III or IV unresectable NSCLC (documented histologic or cytologic diagnosis according to AJCC Cancer Staging).
3. On or planned first line chemotherapy or targeted therapies.
4. ECOG performance status ≤ 2.
5. Estimated life expectancy of \> 6 months at the time of screening.
6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤5 x upper limit of normal (ULN).
7. Adequate renal function, defined as creatinine ≤2 x ULN, or calculated creatinine clearance \>30 ml/minute.
8. 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.
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Exclusion Criteria:
1. Other forms of lung cancer (eg, small cell, mesothelioma)
2. Women who are pregnant or breast-feeding
3. Known HIV, hepatitis (B \& C), or active tuberculosis
4. 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.
5. Patients undergoing curative radiation therapy.
6. Patients on treatment with levodopa.
7. Patients unable to readily swallow. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded.
8. Patients with active, uncontrolled infection.
9. Patients with uncontrolled diabetes mellitus.
10. Patients with untreated, clinically relevant hypothyroidism.
11. Patients with known or symptomatic brain metastases.
12. Patients receiving parenteral nutrition (either total or partial).
13. Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation.
14. Use of other investigational drug(s) within 30 days before study entry or during the study.
\-References
Publications (0)
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