Clinical trial · Interventional
Study of Branched-chain Amino Acids in Cancer Cachexia
Use of Branched-chain Amino Acids in Cancer Cachexia
NCT03253029CI-TRIAL-00029254withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawal of institutional support
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| control group (no BCAAs provided) | Dietary Supplement | — | UNRESOLVED |
| Pure Encapsulations Branched Chain Amino Acid powder | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- 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)
- interventionNames
- Dietary Supplement: Pure Encapsulations Branched Chain Amino Acid powder
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- (arm 2): control group (no BCAAs provided)
- interventionNames
- Dietary Supplement: control group (no BCAAs provided)
Primary outcomes (2)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.