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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

Primary Purpose

Cancer Patients With Cachexia

Status
Withdrawn
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Amixea
Placebo
Sponsored by
Helsinn Healthcare SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Patients With Cachexia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

    -

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.

    -

Sites / Locations

  • Bond University-Department of Nutrition & Dietetics
  • Gold Coast University Hospital
  • Princess Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm Description

Amixea- patented stoechiometrical mixture of EAA & AA

Placebo

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
overall safety and product tolerability
Number and typology of adverse events (AEs), Physical examination and vital signs, Product tolerability

Full Information

First Posted
January 27, 2016
Last Updated
September 19, 2016
Sponsor
Helsinn Healthcare SA
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1. Study Identification

Unique Protocol Identification Number
NCT02877966
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Change of Trial Sponsor
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Patients With Cachexia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Amixea- patented stoechiometrical mixture of EAA & AA
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Amixea
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
effects of an amino acid mixture (Amixea) on the body composition
Description
Lean Body Mass determination with DXA scan and Maximal Voluntary Contraction Force using dynamometer (strain gauge)
Time Frame
10 weeks of treatment
Secondary Outcome Measure Information:
Title
to evaluate the nutritional risk and status and quality of life in advanced NSCLC patients
Description
Nutritional status and risk using the scored Patient-Generated Subjective Global Assessment (PG-SGA) tool
Time Frame
10 weeks of treatment
Title
overall safety and product tolerability
Description
Number and typology of adverse events (AEs), Physical examination and vital signs, Product tolerability
Time Frame
10 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) Women who are pregnant or breast-feeding 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 undergoing curative radiation therapy. Patients on treatment with levodopa. Patients unable to readily swallow. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded. Patients with active, uncontrolled infection. Patients with uncontrolled diabetes mellitus. Patients with untreated, clinically relevant hypothyroidism. Patients with known or symptomatic brain metastases. Patients receiving parenteral nutrition (either total or partial). Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation. Use of other investigational drug(s) within 30 days before study entry or during the study. -
Facility Information:
Facility Name
Bond University-Department of Nutrition & Dietetics
City
Robina
ZIP/Postal Code
QLD 4226
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
ZIP/Postal Code
QLD 4215
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
QLD 4226
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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