Evaluation of the effects of a mixture of amino acids (Amixea) on lean body mass and muscle strength of patients with unresectable advanced non small cell lung cancer: A randomized, double blind, placebo controlled, multicentre study

Phase 2

• Conditions: Advanced non small cell lung cancer; Cachexia; Cancer - Lung - Non small cell; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12616001402437
• Lead Sponsor: atis Australian PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 160

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 less than or equal to 2.
5. Estimated life expectancy greater than 6 months at the time of screening.
6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than or equal to 5 x upper limit of normal (ULN).
7. Adequate renal function, defined as creatinine less than or equal to 2 x ULN, or calculated creatinine clearance greater than 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ean body mass by dual energy x-ray absorptiometry (DXA).<br>[Lean body mass will be evaluated at baseline (before study treatment start) and after 10 weeks of treatment.];Quadriceps maximal voluntary contraction force (QMVC) using dynamometer (strain gauge). <br>[QMVC will be evaluated at baseline (before study treatment start) and after 10 weeks of treatment.]