Study of Branched-chain Amino Acids in Cancer Cachexia

NCT ID: NCT03253029

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-04-30

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).

Conditions

Cancer Cachexia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Pure Encapsulations Branched Chain Amino Acid powder

Intervention Type: DIETARY_SUPPLEMENT

Control

(arm 2): control group (no BCAAs provided)

Group Type: PLACEBO_COMPARATOR

control group (no BCAAs provided)

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Pure Encapsulations Branched Chain Amino Acid powder

Intervention Type: DIETARY_SUPPLEMENT

control group (no BCAAs provided)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jordan Waypa

Jordan Waypa, FNP-C

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

WG2014009

Identifier Type: -

Identifier Source: org_study_id