Cancer CachexiaNCT03253029
Study of Branched-chain Amino Acids in Cancer Cachexia
A study testing Pure Encapsulations Branched Chain Amino Acid powder in people with Cancer Cachexia, run by Western Regional Medical Center.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Pure Encapsulations Branched Chain Amino Acid powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: Use of Branched-chain Amino Acids in Cancer Cachexia
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
- Being tested
- Pure Encapsulations Branched Chain Amino Acid powder, control group (no BCAAs provided)
- Keywords
- oncology, cancer cachexia, cachexia anorexia,
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure Encapsulations Branched Chain Amino Acid powderDietary supplement
control group (no BCAAs provided)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: Pure Encapsulations Branched Chain Amino Acid powder |
| Control | Placebo comparator | (arm 2): control group (no BCAAs provided) Receives: Dietary Supplement: control group (no BCAAs provided) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 12 weeks
Secondary outcomes (1)
Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startApr 2015 (estimated)
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Withdrawal of institutional support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Waypa, Western Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253029
- Sponsor's protocol ID
- WG2014009
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Branched-chain Amino Acids in Cancer Cachexia
- ClinicalTrials.gov ID
- NCT03253029
- Acronym / sponsor ID
- WG2014009
- Conditions
- Cancer Cachexia
- Keywords
- oncology, cancer cachexia, cachexia anorexia,
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of institutional support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Apr 2015 (estimated)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Pure Encapsulations Branched Chain Amino Acid powder(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) |
| Control | Placebo comparator | Dietary Supplement: control group (no BCAAs provided)(arm 2): control group (no BCAAs provided) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure Encapsulations Branched Chain Amino Acid powder | Dietary supplement | Treatment |
| control group (no BCAAs provided) | Dietary supplement | Control |
Primary outcome
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
Time frame: 12 weeks
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)
Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA
Time frame: 12 weeks
Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in bioelectrical impedance assessment (BIA).
1 secondary outcome
Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pure Encapsulations Branched Chain Amino Acid powder in people with Cancer Cachexia, run by Western Regional Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.