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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02877966




Registration number
NCT02877966
Ethics application status
Date submitted
27/01/2016
Date registered
25/08/2016
Date last updated
20/09/2016

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
HF03-14-37
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer Patients With Cachexia 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Amixea
Other interventions - Placebo

Experimental: Arm A - Amixea- patented stoechiometrical mixture of EAA & AA

Placebo Comparator: Arm B - Placebo


Other interventions: Amixea
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.

Other interventions: Placebo


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
10 weeks of treatment
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
10 weeks of treatment
Secondary outcome [2] 0 0
overall safety and product tolerability - Number and typology of adverse events (AEs), Physical examination and vital signs, Product tolerability
Timepoint [2] 0 0
10 weeks of treatment

Eligibility
Key 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.

-
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bond University-Department of Nutrition & Dietetics - Robina
Recruitment hospital [2] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
QLD 4226 - Robina
Recruitment postcode(s) [2] 0 0
QLD 4215 - Southport
Recruitment postcode(s) [3] 0 0
QLD 4226 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Helsinn Healthcare SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02877966
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02877966