Cancer Cachexia
Conditions
Keywords
oncology, cancer cachexia, cachexia anorexia,
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTPure Encapsulations Branched Chain Amino Acid powder
DIETARY_SUPPLEMENTcontrol group (no BCAAs provided)
Sponsors
Western Regional Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and LBM based on body weight in kg | 12 weeks | 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) |
| Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA | 12 weeks | Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in bioelectrical impedance assessment (BIA). |
Secondary
| Measure | Time frame |
|---|---|
| Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI). | 12 weeks |
Outcome results
None listed