Study of Branched-chain Amino Acids in Cancer Cachexia

Use of Branched-chain Amino Acids in Cancer Cachexia

Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (LBM) based on body weight in kilograms (kg) and bioelectrical impedance assessment (BIA).

Inclusion Criteria:

1. 18 years of age or older

2. Eastern Cooperative Oncology Group (ECOG) performance status score < 2 and a life expectancy >3 months

3. Participants must have evaluable disease by RECIST 1.1 criteria17

4. At least four (4) weeks from prior major surgery

5. Participants must be cachectic as defined by the guidelines below18

   • >5% weight loss over the past 6 months (in absence of simple starvation); OR
   • BMI <20 and any degree of weight loss >2%; OR
   • Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men <14.6 kg/m²; women <11.4 kg/m²) and weight loss >2%

6. Participants must be anorexic as defined by reporting one of the following symptoms below3

   • Early satiety
   • Nausea/vomiting
   • Taste alterations
   • Smell alterations
   • Meat aversion

Exclusion Criteria:

1. Patients taking Levadopa
2. Patients with amyotrophic lateral sclerosis (ALS)
3. Patients utilizing a percutaneous gastrostomy tube for drainage
4. Patients unable to consume food or beverage orally
5. Patients on any form of parenteral nutrition which contains BCAA.
6. Serious non-healing wound, ulcer, or burn
7. Patients who are pregnant or lactating
8. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
9. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements