Study of Branched-chain Amino Acids in Cancer Cachexia

Study Overview
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Brief Summary
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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).

Official Title
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Use of Branched-chain Amino Acids in Cancer Cachexia

Conditions
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Cancer Cachexia

Intervention / Treatment
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* Dietary Supplement: Pure Encapsulations Branched Chain Amino Acid powder
* Dietary Supplement: control group (no BCAAs provided)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>(arm 1) consume five scoops total per day of Pure Encapsulations Branched Chain Amino Acid powder on an outpatient basis (take 2 scoops both in the morning and afternoon and 1 scoop in the evening) | Dietary Supplement: Pure Encapsulations Branched Chain Amino Acid powder<br> <br> |
| Placebo Comparator: Control<br>(arm 2): control group (no BCAAs provided) | Dietary Supplement: control group (no BCAAs provided)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 12 weeks | 
| Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA | Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in bioelectrical impedance assessment (BIA). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI). |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oncology, cancer cachexia, cachexia anorexia,