Study of Branched-chain Amino Acids in Cancer Cachexia

NCT03253029 | Withdrawn

• 1 other identifier: WG2014009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

oncology, cancer cachexia, cachexia anorexia,

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

(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

Control

PLACEBO COMPARATOR

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

Dietary Supplement: control group (no BCAAs provided)

Interventions

Pure Encapsulations Branched Chain Amino Acid powder DIETARY_SUPPLEMENT

Treatment

control group (no BCAAs provided) DIETARY_SUPPLEMENT

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Regional Medical Center: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jordan Waypa, FNP-C

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 24, 2017

Record last verified: 2017-08