<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253029</url>
  </required_header>
  <id_info>
    <org_study_id>WG2014009</org_study_id>
    <nct_id>NCT03253029</nct_id>
  </id_info>
  <brief_title>Study of Branched-chain Amino Acids in Cancer Cachexia</brief_title>
  <official_title>Use of Branched-chain Amino Acids in Cancer Cachexia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Regional Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive&#xD;
      effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body&#xD;
      mass (LBM) based on body weight in kilograms (kg) and bioelectrical impedance assessment&#xD;
      (BIA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawal of institutional support&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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</measure>
    <time_frame>12 weeks</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in BIA</measure>
    <time_frame>12 weeks</time_frame>
    <description>Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in bioelectrical impedance assessment (BIA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cancer Cachexia</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>(arm 2): control group (no BCAAs provided)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pure Encapsulations Branched Chain Amino Acid powder</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>control group (no BCAAs provided)</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status score &lt; 2 and a life&#xD;
             expectancy &gt;3 months&#xD;
&#xD;
          3. Participants must have evaluable disease by RECIST 1.1 criteria17&#xD;
&#xD;
          4. At least four (4) weeks from prior major surgery&#xD;
&#xD;
          5. Participants must be cachectic as defined by the guidelines below18&#xD;
&#xD;
               -  &gt;5% weight loss over the past 6 months (in absence of simple starvation); OR&#xD;
&#xD;
               -  BMI &lt;20 and any degree of weight loss &gt;2%; OR&#xD;
&#xD;
               -  Appendicular skeletal muscle index consistent with sarcopenia (whole body&#xD;
                  fat-free mass index without bone determined by bioelectrical impedance (men &lt;14.6&#xD;
                  kg/m²; women &lt;11.4 kg/m²) and weight loss &gt;2%&#xD;
&#xD;
          6. Participants must be anorexic as defined by reporting one of the following symptoms&#xD;
             below3&#xD;
&#xD;
               -  Early satiety&#xD;
&#xD;
               -  Nausea/vomiting&#xD;
&#xD;
               -  Taste alterations&#xD;
&#xD;
               -  Smell alterations&#xD;
&#xD;
               -  Meat aversion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients taking Levadopa&#xD;
&#xD;
          2. Patients with amyotrophic lateral sclerosis (ALS)&#xD;
&#xD;
          3. Patients utilizing a percutaneous gastrostomy tube for drainage&#xD;
&#xD;
          4. Patients unable to consume food or beverage orally&#xD;
&#xD;
          5. Patients on any form of parenteral nutrition which contains BCAA.&#xD;
&#xD;
          6. Serious non-healing wound, ulcer, or burn&#xD;
&#xD;
          7. Patients who are pregnant or lactating&#xD;
&#xD;
          8. Inability to complete informed consent process and adhere to the protocol treatment&#xD;
             plan and follow-up requirements&#xD;
&#xD;
          9. Concurrent severe illness such as active infection, or psychiatric illness/social&#xD;
             situations that would limit safety and compliance with study requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Regional Medical Center</investigator_affiliation>
    <investigator_full_name>Jordan Waypa</investigator_full_name>
    <investigator_title>Jordan Waypa, FNP-C</investigator_title>
  </responsible_party>
  <keyword>oncology, cancer cachexia, cachexia anorexia,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wasting Syndrome</mesh_term>
    <mesh_term>Cachexia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253029
org study id: WG2014009
nct id: NCT03253029
lead sponsor: 
has dmc: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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
description: 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)
measure: 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
description: Investigate whether supplementation with BCAAs has a positive effect on cancer cachexia, as measured by the maintenance or increase in bioelectrical impedance assessment (BIA).
measure: Examine whether supplementation with BCAAs improve appetite and quality of life based on the MD Anderson Symptom Inventory (MDASI).
time frame: 12 weeks
arm group label: Treatment
arm group type: Experimental
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)
arm group label: Control
arm group type: Placebo Comparator
description: (arm 2): control group (no BCAAs provided)
intervention type: Dietary Supplement
intervention name: Pure Encapsulations Branched Chain Amino Acid powder
arm group label: Treatment
intervention type: Dietary Supplement
intervention name: control group (no BCAAs provided)
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Western Regional Medical Center
investigator full name: Jordan Waypa
investigator title: Jordan Waypa, FNP-C
mesh term: Wasting Syndrome
mesh term: Cachexia