Not Yet RecruitingPhase 2ACTRN12616001402437

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

Evaluation of the effects of a stoichiometric 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

Sponsor

Latis Australian PTY LTD

Enrollment

160 participants

Start Date

Nov 30, 2016

Study Type

Interventional

Conditions

Cachexia

Summary

The aim of this clinical study is to investigate whether a new food supplement called Amixea can prevent or slow the loss of muscle mass and strength in patients with non small cell lung cancer undergoing chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with Stage III or IV unresectable non small cell lung cancer (NSCLC) for which you are undergoing, or plan to undergo chemotherapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take a new food supplement called Amixea 3 times a day for 10 weeks. Amixea is a mixture of amino acids designed to prevent or slow the loss of muscle mass and strength in patients with cancer, particularly in those who show signs of cachexia. Participants in the other group will instead take a placebo (inactive) treatment for 10 weeks. The study will be double blind, which means that neither the patient nor the investigators will know which treatment the patients are receiving until after the study is completed. All participants will undergo a number of assessments before and after the 10 week treatment period, including dual-energy X-ray absorptiometry (DEXA) scans to evaluate body composition, muscle strength testing of the quadriceps (thigh muscles), and blood tests. They will also be asked to complete a number of questionnaires to evaluate nutritional status, quality of life, satisfaction with treatment, adherence and product tolerability. Results from patients treated with Amixea will be compared to those obtained from patients treated with placebo, in order to investigate the study product effects on cachexia.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria8

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 less than or equal to 2.
Estimated life expectancy greater than 6 months at the time of screening.
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).
Adequate renal function, defined as creatinine less than or equal to 2 x ULN, or calculated creatinine clearance greater than 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 Criteria14

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.

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Interventions

This clinical study is aimed to evaluate the efficacy of a new food supplement called "Amixea" in improving muscle strength and body composition in cancer patients, when compared to placebo. Amixea i

This clinical study is aimed to evaluate the efficacy of a new food supplement called "Amixea" in improving muscle strength and body composition in cancer patients, when compared to placebo. Amixea is a mixture of amino acids. It consists mainly of essential amino acids (EAA). List of characterizing ingredients in Amixea: L-leucine L-lysine chloride L-isoleucine L-valine L-threonine L-histidine chloride monohydrate L-cystine L-phenylalanine L-methionine L-tyrosine L-tryptophan Each sachet will be of 6.6 mg (including active ingredients abov listed and excipients). Amixea will be administered orally for 10 weeks: 3 sachets per day. Each sachet will be taken with approximately 150 ml of chilled water, 30 minutes after food. The patients’ compliance to the treatment will be checked by the study staff by counting the number of used and unused sachets returned by the patients at Visit 3 and 4.