Status:
WITHDRAWN
Study of Branched-chain Amino Acids in Cancer Cachexia
Lead Sponsor:
Western Regional Medical Center
Conditions:
Cancer Cachexia
Eligibility:
All Genders
18+ years
Phase:
NA
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) base...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status score \< 2 and a life expectancy \>3 months
- Participants must have evaluable disease by RECIST 1.1 criteria17
- At least four (4) weeks from prior major surgery
- 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%
- 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
- Patients taking Levadopa
- Patients with amyotrophic lateral sclerosis (ALS)
- Patients utilizing a percutaneous gastrostomy tube for drainage
- Patients unable to consume food or beverage orally
- Patients on any form of parenteral nutrition which contains BCAA.
- Serious non-healing wound, ulcer, or burn
- Patients who are pregnant or lactating
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03253029
Start Date
April 1 2015
End Date
April 1 2016
Last Update
August 24 2017
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