Cancer Patients With Cachexia Clinical Trial
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2018 |
| Est. primary completion date | August 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 99 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Australia | Bond University-Department of Nutrition & Dietetics | Robina | |
| Australia | Gold Coast University Hospital | Southport | |
| Australia | Princess Alexandra Hospital | Woolloongabba |
| Lead Sponsor | Collaborator |
|---|---|
| Helsinn Healthcare SA |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | 10 weeks of treatment | No |
| Secondary | 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 | 10 weeks of treatment | No |
| Secondary | overall safety and product tolerability | Number and typology of adverse events (AEs), Physical examination and vital signs, Product tolerability | 10 weeks of treatment | Yes |