Cancer Patients With CachexiaNCT02877966
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
A study testing Amixea in people with Cancer Patients With Cachexia, run by Helsinn Healthcare SA at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Patients With Cachexia
- What is being tested?
- Amixea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesAustralia
- Study dates
- Oct 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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.
- -
Who cannot join
- 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.
Show all 15Show fewer
- 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.
- -
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Bond University-Department of Nutrition & Dietetics
Robina, QLD 4226
Gold Coast University Hospital
Southport, QLD 4215
Princess Alexandra Hospital
Woolloongabba, QLD 4226
About this study
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
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.
Read the 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.
- Conditions
- Cancer Patients With Cachexia
- Being tested
- Amixea, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmixeaDietary supplement
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.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Amixea- patented stoechiometrical mixture of EAA \& AA Receives: Dietary Supplement: Amixea |
| Arm B | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 weeks of treatment
Secondary outcomes (2)
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
Measured: 10 weeks of treatment
overall safety and product tolerability
Number and typology of adverse events (AEs), Physical examination and vital signs, Product tolerability
Measured: 10 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Change of Trial Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients With CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877966
- Sponsor's protocol ID
- HF03-14-37
- Status last verified
- Sep 2016
- First submitted
- 27 Jan 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02877966
- Acronym / sponsor ID
- HF03-14-37
- Conditions
- Cancer Patients With Cachexia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of Trial Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Dietary Supplement: AmixeaAmixea- patented stoechiometrical mixture of EAA \& AA |
| Arm B | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmixeaAmixea 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. | Dietary supplement | Arm A |
| Placebo | Other | Arm B |
Primary outcome
effects of an amino acid mixture (Amixea) on the body composition
Time frame: 10 weeks of treatment
Lean Body Mass determination with DXA scan and Maximal Voluntary Contraction Force using dynamometer (strain gauge)
2 secondary outcomes
to evaluate the nutritional risk and status and quality of life in advanced NSCLC patients
Time frame: 10 weeks of treatment
overall safety and product tolerability
Time frame: 10 weeks of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Cancer Patients With Cachexia
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
RecruitingPhase 2/3
Visugromab in Cachexia International Trial
Cancer-associated Cachexia
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amixea in people with Cancer Patients With Cachexia, run by Helsinn Healthcare SA at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of an amino acid mixture (Amixea) on the body composition (time frame: 10 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.