<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/NCT02990130</url>
  </required_header>
  <id_info>
    <org_study_id>00935</org_study_id>
    <nct_id>NCT02990130</nct_id>
  </id_info>
  <brief_title>Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation</brief_title>
  <official_title>Biochemical and Physiologic Factors That Affect Patient Fitness and Body Composition During Hematopoietic Stem Cell Transplantation for Hematologic Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Garcia, Jose M., MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Garcia, Jose M., MD, PhD</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposal aims to characterize biochemical and physiologic factors that contribute to&#xD;
      changes in patient fitness and body composition during hematopoietic stem cell&#xD;
      transplantation (HCT) for hematologic malignancies. The study group will consist of 60&#xD;
      patients with hematologic malignancies treated with HCT. Measurements of patient fitness,&#xD;
      body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days&#xD;
      (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA,&#xD;
      additional visits (not exceeding 6 total) may be requested periodically for up to 2 years&#xD;
      after HCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This proposal aims to characterize biochemical and physiologic factors that contribute to&#xD;
      changes in patient fitness and body composition during hematopoietic stem cell&#xD;
      transplantation (HCT) for hematologic malignancies. The investigators hypothesize that: 1)&#xD;
      HCT for hematologic malignancies is associated with a change in biochemical and physiologic&#xD;
      factors that reflect patient fitness and 2) Baseline (pre-HCT) and post-HCT changes of&#xD;
      biochemical and physiologic factors that reflect patient fitness are associated with&#xD;
      HCT-related clinical outcomes.This is a pilot study involving patients enrolled in the&#xD;
      Seattle VA Bone Marrow Transplant Unit (BMTU) for treatment of their hematologic malignancy.&#xD;
      No vulnerable population will be included. The study group will consist of 60 patients with&#xD;
      hematologic malignancies treated with HCT.&#xD;
&#xD;
      Measurements of patient fitness, body composition, and inflammatory milieu will be performed&#xD;
      at visits before HCT, and 30 days (+/- 10 days) after HCT. For patients that continue to&#xD;
      receive care at the Seattle VA, additional visits (not exceeding 6 total) may be requested&#xD;
      periodically for up to 2 years after HCT. Data collection may include:&#xD;
&#xD;
        1. Blood tests other than those performed as clinical standard of care may include:&#xD;
           anabolic and catabolic factors such as IGF-1, GH, IGFBP-3, free and weakly bound&#xD;
           testosterone, IL-6, CRP, TNF-alpha, and pre-albumin.&#xD;
&#xD;
        2. Measurements of fitness other than those obtained as clinical standard of care may&#xD;
           include: resting energy expenditure (REE) assessed by indirect calorimetry; body&#xD;
           composition measured by bio-impedance (BIA) and dual-energy x-ray absorptiometry (DEXA)&#xD;
           scan; handgrip strength; stair climbing power; 6-minute walk test; muscle strength;&#xD;
           maximal oxygen consumption (VO2 max); and previously validated questionnaires to assess&#xD;
           patient quality of life (QOL) and functional status.&#xD;
&#xD;
        3. Additional data that may be collected for this protocol will include clinical and&#xD;
           laboratory data acquired per standard of clinical care as pertains to subjects'&#xD;
           co-morbidities, hematologic disease and treatment history, and clinical course including&#xD;
           nutritional status, use of nutrition support, and estimated nutritional requirements per&#xD;
           routine dietitian assessments. A Food Frequency Questionnaire will be administered by a&#xD;
           dietitian in addition to the routine clinical assessments.&#xD;
&#xD;
      The primary endpoint of this study is the change over time of patient fitness as assessed by&#xD;
      the 6 minute walk test through HCT. Secondary endpoints will include other markers of&#xD;
      anabolism and catabolism, and data collected as mentioned above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Actual">December 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>6-Minute Walk Test change</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>maximum distance walked in 6 minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anabolic marker changes</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>IGF-1, GH, IGFBP-3, free and weakly bound testosterone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory marker changes</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>IL-6, CRP, TNF-alpha, and pre-albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>handgrip strength; 1-RM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting energy expenditure changes</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>indirect calorimetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition changes</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>bio-impedance and dual-energy x-ray absorptiometry (all in kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical function changes</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>stair climbing power</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal oxygen consumption changes</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>VO2 max</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life change score</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>ASAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life change score</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>FACIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life change score</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>Karnofsky</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life change score</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
    <description>ECOG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Frequency Questionnaire</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nutritional status</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of nutrition support</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated nutritional requirements</measure>
    <time_frame>from baseline to 30 days (+/- 10 days) after HCT</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hematologic Malignancy</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>This is a pilot observational study involving patients enrolled in the Seattle VA Bone Marrow Transplant Unit (BMTU) for treatment of their hematologic malignancy. Measurements of patient fitness, body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA, additional visits (not exceeding 6 total) may be requested periodically for up to 2 years after HCT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study group will consist of 60 patients with hematologic malignancies treated with HCT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed hematologic malignancy.&#xD;
&#xD;
          -  Undergoing evaluation at the BMTU at the Puget Sound VA.&#xD;
&#xD;
          -  Planning or receiving an autologous or allogeneic HCT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients who for any reason elect not to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02990130
org study id: 00935
nct id: NCT02990130
lead sponsor: 
has dmc: No
This proposal aims to characterize biochemical and physiologic factors that contribute to
      changes in patient fitness and body composition during hematopoietic stem cell
      transplantation (HCT) for hematologic malignancies. The study group will consist of 60
      patients with hematologic malignancies treated with HCT. Measurements of patient fitness,
      body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days
      (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA,
      additional visits (not exceeding 6 total) may be requested periodically for up to 2 years
      after HCT.
This proposal aims to characterize biochemical and physiologic factors that contribute to
      changes in patient fitness and body composition during hematopoietic stem cell
      transplantation (HCT) for hematologic malignancies. The investigators hypothesize that: 1)
      HCT for hematologic malignancies is associated with a change in biochemical and physiologic
      factors that reflect patient fitness and 2) Baseline (pre-HCT) and post-HCT changes of
      biochemical and physiologic factors that reflect patient fitness are associated with
      HCT-related clinical outcomes.This is a pilot study involving patients enrolled in the
      Seattle VA Bone Marrow Transplant Unit (BMTU) for treatment of their hematologic malignancy.
      No vulnerable population will be included. The study group will consist of 60 patients with
      hematologic malignancies treated with HCT.

      Measurements of patient fitness, body composition, and inflammatory milieu will be performed
      at visits before HCT, and 30 days (+/- 10 days) after HCT. For patients that continue to
      receive care at the Seattle VA, additional visits (not exceeding 6 total) may be requested
      periodically for up to 2 years after HCT. Data collection may include:

        1. Blood tests other than those performed as clinical standard of care may include:
           anabolic and catabolic factors such as IGF-1, GH, IGFBP-3, free and weakly bound
           testosterone, IL-6, CRP, TNF-alpha, and pre-albumin.

        2. Measurements of fitness other than those obtained as clinical standard of care may
           include: resting energy expenditure (REE) assessed by indirect calorimetry; body
           composition measured by bio-impedance (BIA) and dual-energy x-ray absorptiometry (DEXA)
           scan; handgrip strength; stair climbing power; 6-minute walk test; muscle strength;
           maximal oxygen consumption (VO2 max); and previously validated questionnaires to assess
           patient quality of life (QOL) and functional status.

        3. Additional data that may be collected for this protocol will include clinical and
           laboratory data acquired per standard of clinical care as pertains to subjects'
           co-morbidities, hematologic disease and treatment history, and clinical course including
           nutritional status, use of nutrition support, and estimated nutritional requirements per
           routine dietitian assessments. A Food Frequency Questionnaire will be administered by a
           dietitian in addition to the routine clinical assessments.

      The primary endpoint of this study is the change over time of patient fitness as assessed by
      the 6 minute walk test through HCT. Secondary endpoints will include other markers of
      anabolism and catabolism, and data collected as mentioned above.
observational model: Cohort
time perspective: Prospective
measure: 6-Minute Walk Test change
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: maximum distance walked in 6 minutes
measure: Anabolic marker changes
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: IGF-1, GH, IGFBP-3, free and weakly bound testosterone
measure: Inflammatory marker changes
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: IL-6, CRP, TNF-alpha, and pre-albumin
measure: Muscle strength
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: handgrip strength; 1-RM
measure: resting energy expenditure changes
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: indirect calorimetry
measure: body composition changes
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: bio-impedance and dual-energy x-ray absorptiometry (all in kg)
measure: physical function changes
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: stair climbing power
measure: maximal oxygen consumption changes
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: VO2 max
measure: Quality of Life change score
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: ASAS
measure: Quality of Life change score
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: FACIT
measure: Quality of Life change score
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: Karnofsky
measure: Quality of Life change score
time frame: from baseline to 30 days (+/- 10 days) after HCT
description: ECOG
measure: Food Frequency Questionnaire
time frame: from baseline to 30 days (+/- 10 days) after HCT
measure: nutritional status
time frame: from baseline to 30 days (+/- 10 days) after HCT
measure: use of nutrition support
time frame: from baseline to 30 days (+/- 10 days) after HCT
measure: estimated nutritional requirements
time frame: from baseline to 30 days (+/- 10 days) after HCT
arm group label: Study Group
description: This is a pilot observational study involving patients enrolled in the Seattle VA Bone Marrow Transplant Unit (BMTU) for treatment of their hematologic malignancy. Measurements of patient fitness, body composition, and inflammatory milieu will be performed at visits before HCT, and 30 days (+/- 10 days) after HCT. For patients that continue to receive care at the Seattle VA, additional visits (not exceeding 6 total) may be requested periodically for up to 2 years after HCT.
intervention type: Other
intervention name: Observational
arm group label: Study Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms
sharing ipd: No