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).

Study Overview

• Status: Withdrawn
• Conditions: Cancer Cachexia
• Intervention / Treatment: Dietary supplement: Pure Encapsulations Branched Chain Amino Acid powder; Dietary supplement: control group (no BCAAs provided)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; (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
Placebo Comparator: Control; (arm 2): control group (no BCAAs provided)	Dietary supplement: control group (no BCAAs provided)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Western Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: oncology, cancer cachexia, cachexia anorexia,
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: WG2014009