<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/NCT03012139</url>
  </required_header>
  <id_info>
    <org_study_id>16-007030</org_study_id>
    <nct_id>NCT03012139</nct_id>
  </id_info>
  <brief_title>Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology</brief_title>
  <official_title>Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to gain a better understanding of the mechanisms leading to muscle&#xD;
      wasting and metabolic abnormalities in skeletal muscle of cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">October 11, 2019</completion_date>
  <primary_completion_date type="Actual">October 11, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Skeletal muscle oxidative capacity</measure>
    <time_frame>Approximately within a month of recruitment</time_frame>
    <description>Muscle oxidative capacity will be measured by magnetic resonance spectroscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skeletal muscle protein synthesis</measure>
    <time_frame>Approximately within a month of recruitment</time_frame>
    <description>Muscle protein synthesis will be measured in the postabsorptive state from the rate of incorporation of isotopically labeled amino acids given intravenously.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">31</enrollment>
  <condition>Metastatic Cancer</condition>
  <condition>Cachexia; Cancer</condition>
  <arm_group>
    <arm_group_label>Cancer with cachexia</arm_group_label>
    <description>Men and women (ages 35-80 years) with cancer cachexia (≥5% drop in body mass in less than 12 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cancer without cachexia</arm_group_label>
    <description>Men and women (ages 35-80 years) with cancer but without cachexia of similar age and sex as the group with cachexia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No cancer</arm_group_label>
    <description>Men and women (ages 35-80 years) without cancer, but similar age and sex as groups with cancer.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, serum, and skeletal muscle tissue will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will recruit patients with metastatic cancer with or without evidence of&#xD;
        cachexia, defined as ≥5% drop in body mass in less than 12 months. Controls without cancer&#xD;
        but similar in age, sex, and body mass index will be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 35-80 years&#xD;
&#xD;
          -  Diagnosis of metastatic cancer with cachexia (≥5% drop in body mass in less than 12&#xD;
             months), metastatic cancer without cachexia (&lt;5% drop in body mass in 12 months) or no&#xD;
             history of cancer but similar in age and sex as other groups.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of vitamin D analogs&#xD;
&#xD;
          -  Fasting plasma glucose ≥126 mg/dL&#xD;
&#xD;
          -  Renal failure (serum creatinine &gt; 1.5mg/dl)&#xD;
&#xD;
          -  Chronic active liver disease (Bilirubin &gt; 17mmol/L, AST&gt;144IU/L, or ALT&gt;165IU/L)&#xD;
&#xD;
          -  Contraindications to MRI (e.g., pacemaker, ferrous materials within body).&#xD;
&#xD;
          -  Active coronary artery disease or history of unstable macrovascular disease (unstable&#xD;
             angina, myocardial infarction, stroke, and revascularization of coronary, peripheral&#xD;
             or carotid artery within 3 months of recruitment)&#xD;
&#xD;
          -  Renal insufficiency/failure (serum creatinine &gt; 1.5mg/dl)&#xD;
&#xD;
          -  Oral warfarin group medications or history of blood clotting disorders.&#xD;
&#xD;
          -  People who have taken Bevacizumab&#xD;
&#xD;
          -  Platelet count &lt;100,000 per uL&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Alcohol consumption greater than 2 glasses/day or other substance abuse&#xD;
&#xD;
          -  Untreated or uncontrolled thyroid disorders&#xD;
&#xD;
          -  Debilitating chronic disease (at the discretion of the investigators)&#xD;
&#xD;
          -  Previous injury/trauma/surgery to the region being measured without full recovery&#xD;
&#xD;
          -  Pain in the area to be assessed&#xD;
&#xD;
          -  Any medical condition affecting the ability to execute a maximal muscle contraction&#xD;
&#xD;
          -  The presence of infections, highly communicable diseases (AIDS, active tuberculosis,&#xD;
             veneral disease, hepatitis) or metastatic bone disease that may interfere with safely&#xD;
             executing maximal effort.&#xD;
&#xD;
          -  Significant neurological or musculoskeletal disorders or disease that may interfere&#xD;
             with safely executing maximal contraction&#xD;
&#xD;
          -  Any congenital, developmental, or other bone disease or previous surgeries that may&#xD;
             interfere with successful testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajiv Kumar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 16, 2020</last_update_submitted>
  <last_update_submitted_qc>January 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Rajiv Kumar, M.D.</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
    <mesh_term>Cachexia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03012139
org study id: 16-007030
nct id: NCT03012139
lead sponsor: 
has dmc: No
This study is designed to gain a better understanding of the mechanisms leading to muscle
      wasting and metabolic abnormalities in skeletal muscle of cancer patients.
observational model: Cohort
time perspective: Cross-Sectional
measure: Skeletal muscle oxidative capacity
time frame: Approximately within a month of recruitment
description: Muscle oxidative capacity will be measured by magnetic resonance spectroscopy
measure: Skeletal muscle protein synthesis
time frame: Approximately within a month of recruitment
description: Muscle protein synthesis will be measured in the postabsorptive state from the rate of incorporation of isotopically labeled amino acids given intravenously.
arm group label: Cancer with cachexia
description: Men and women (ages 35-80 years) with cancer cachexia (≥5% drop in body mass in less than 12 months)
arm group label: Cancer without cachexia
description: Men and women (ages 35-80 years) with cancer but without cachexia of similar age and sex as the group with cachexia
arm group label: No cancer
description: Men and women (ages 35-80 years) without cancer, but similar age and sex as groups with cancer.
Plasma, serum, and skeletal muscle tissue will be collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rajiv Kumar, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Rajiv Kumar, M.D.
investigator title: PI
mesh term: Muscular Atrophy
mesh term: Atrophy
mesh term: Cachexia
sharing ipd: Undecided