Study of Branched-chain Amino Acids in Cancer Cachexia

Western Regional Medical Center

Status: Withdrawn

Conditions: Cancer Cachexia

Treatments: Dietary Supplement: control group (no BCAAs provided); Dietary Supplement: Pure Encapsulations Branched Chain Amino Acid powder

Study type: Interventional

Funder types: Other

Identifiers

NCT03253029

WG2014009

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

(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)

Treatment:

Dietary Supplement: Pure Encapsulations Branched Chain Amino Acid powder

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: control group (no BCAAs provided)