Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, Weight loss, protein metabolism, essential amino acid intake
Brief summary
Weight loss commonly occurs in lung cancer patients, negatively influencing their quality of life, treatment response and survival. Gains in lean body mass are difficult to achieve in cancer unless specific metabolic abnormalities are targeted. It is our hypothesis that a nutritional supplement containing a high amount of essential amino acids will target the metabolic alterations of cancer patients. Preliminary research performed in our laboratory in elderly supports this hypothesis. We hypothesize that intake of an essential amino acid nutritional supplement will positively influence protein synthesis rate in advanced non-small cell lung cancer (NSCLC) patients. Furthermore, insight in the underlying mechanism of the higher anabolic response of the essential amino acid supplement will be examined. This information will potentially enable us to formulate a supplement that is more effective than normal food intake, and that will reduce the need for muscle protein breakdown.
Detailed description
In this study, we will test the following hypothesis: A high-leucine essential amino acid mixture stimulates whole body protein synthesis (and in this way protein anabolism) to a larger extent than a regular balanced mixture of total (essential and non-essential) amino acids in NSCLC patients with and without recent weight loss. The principal endpoint will be the extent of stimulation of protein synthesis rate as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism. This project will provide important clinical information, based on novel fundamental basic knowledge on the process and the specific underlying mechanisms of muscle wasting in patients with NSCLC, and the role of EAA as a potential anabolic substrate. In this way, it will provide preliminary data for the development of nutritional strategies that will prevent or even stop this process of ongoing muscle loss in NSCLC.
Interventions
DIETARY_SUPPLEMENTEAA+LEU vs total AA
15 g as a bolus
DIETARY_SUPPLEMENTTotal AA vs EAA+LEU
15 g as a bolus
Sponsors
University of Arkansas
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Recently diagnosed with Stage III (unresectable) or Stage IV lung cancer (only for the NSCLC group) 2. Ability to sign informed consent 3. Age 40 years and older
Exclusion criteria
1. Previous anti-cancer therapy (e.g. radiotherapy, chemotherapy) or surgery less than 4 weeks prior to the experiment. 2. Presence of fever within the last 3 days 3. Established diagnosis of Diabetes Mellitus 4. BMI \> 35 kg/m2 5. Untreated metabolic diseases including hepatic or renal disorder 6. Presence of acute illness or metabolically unstable chronic illness 7. Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment 8. Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of referen¬ce FEV1 (only for the healthy control group) 9. Use of supplements enriched with amino acids 10. Any other condition according to the PI or study physicians would interfere with proper conduct of the study / safety of the patient 11. Failure to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute change in Net whole body protein synthesis rate | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute change in Whole body myofibrillar protein breakdown rate | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
| Acute change in Whole body collagen breakdown rate | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
| Acute change in Arginine turnover rate | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
| Acute change in Urea turnover rate | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
| Acute change in plasma Insulin concentrations | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
| Acute change in plasma Amino acid concentrations | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
| Acute change in plasma Glucose concentrations | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
| Acute change in Liver protein synthesis rate | Up to 2 years | Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement |
Countries
United States
Outcome results
None listed