Study of Branched-chain Amino Acids in Cancer Cachexia

Not Applicable

Withdrawn

• Conditions: Cancer Cachexia
• Interventions: Dietary Supplement: Pure Encapsulations Branched Chain Amino Acid powder; Dietary Supplement: control group (no BCAAs provided)

• Registration Number: NCT03253029
• Lead Sponsor: Western Regional Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-08
• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-17
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Pure Encapsulations Branched Chain Amino Acid powder	(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)
Control	control group (no BCAAs provided)	(arm 2): control group (no BCAAs provided)

Primary Outcome Measures

Name	Time	Method
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).
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)

Secondary Outcome Measures

Name	Time	Method
Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).	12 weeks