Study of Branched-chain Amino Acids in Cancer Cachexia

Cancer Cachexia Clinical Trial

Official title:

Use of Branched-chain Amino Acids in Cancer Cachexia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03253029
• Other study ID #: WG2014009
• Status: Withdrawn
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 22, 2017
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2017
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

Dietary Supplement:
• Pure Encapsulations Branched Chain Amino Acid powder

• control group (no BCAAs provided)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).		12 weeks