xml: <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/NCT05978960</url>
    </required_header>
    <id_info>
      <org_study_id>2023-131-SG</org_study_id>
      <nct_id>NCT05978960</nct_id>
    </id_info>
    <brief_title>EXERT-BCN: An Exercise and Nutrition Regimen to Designed to Improve Body Composition After Treatment for Breast Cancer</brief_title>
    <acronym>EXERT-BCN</acronym>
    <official_title>An EXErcise Regimen Designed to Improve Body Composition, Functional Capacity, and Strength After Treatment for Breast Cancer With Nutrition Optimization</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This protocol seeks to analyze patient outcomes of the standard of care, monitored group&#xD;
        exercise regimen of high-load resistance training and functional exercises with compound&#xD;
        movements in conjunction with a nutrition regimen focused on food quality under close&#xD;
        supervision on women who have been treated for breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Excess adipose tissue is a risk factor for the diagnosis of breast cancer and is also&#xD;
        associated with an increased risk of disease recurrence.1 Additionally weight gain during and&#xD;
        after treatment for breast cancer is associated with a higher risk of recurrence, distant&#xD;
        metastases, and death.2 More specifically, low muscle mass and increased adipose tissue is&#xD;
        associated with poorer outcomes after the treatment of breast cancer.3 Yet, most women gain&#xD;
        significant weight during and after breast cancer treatment, potentially compromising&#xD;
        outcomes.&#xD;
  &#xD;
        Effective methods to promote weight loss and improve metabolic and hormonal dysregulation,&#xD;
        inflammation, and body composition in the breast cancer setting are urgently needed. In the&#xD;
        noncancer setting, the promotion of high-quality diets that avoided processed food and simple&#xD;
        carbohydrates in the DIETFITS study promoted weight loss4. However, this dietary strategy and&#xD;
        others were utilized to result in weight loss, but do not necessarily consider maximizing&#xD;
        body composition, i.e., muscle mass preservation or increase, and adipose tissue loss.&#xD;
  &#xD;
        The major, and some would consider only, non-pharmacological method to increase muscle mass&#xD;
        is via resistance training with an adequate stimulus and quantity to elicit and promote&#xD;
        hypertrophy.5 Our group has already shown that profound muscle hypertrophy is attainable in a&#xD;
        population of women undergoing treatment for breast cancer, particularly when the dose&#xD;
        threshold of load and repetitions is met. At interim analysis, this program revealed a 2 lb.&#xD;
        increase in muscle mass and a 6 lb. decrease in adipose tissue after a 3 month program&#xD;
        utilizing linear progression.&#xD;
  &#xD;
        Based on the DIEFITS protocol which has been described as a &quot;healthy low-carbohydrate&quot; diet,&#xD;
        participants will be advised to eat nutrient dense food sources high in vitamins, minerals,&#xD;
        and nutrients. Participants will be told to limit processed foods, sugar, bread, pasta, and&#xD;
        other simple carbohydrates. Participants will be advised to eat plenty of colorful and&#xD;
        nonstarchy vegetables. Finally, participants will be told to avoid snacking between meals,&#xD;
        cook most/all meals, eat with family and friends, avoid eating food in the car or on the run,&#xD;
        and focus on whole foods that require preparation. This protocol resulted in significant&#xD;
        weight loss at one year. Additionally, the lack of calculations and quantification of&#xD;
        calories leaves this as a more user-friendly option for participants.&#xD;
  &#xD;
        The exercise regimen from EXERT-BC has yet to be combined with a dietary intervention. Thus,&#xD;
        the following protocol will assess our resistance training regimen in conjunction with a&#xD;
        nutrition intervention similar to the DIETFITS Protocol. This will allow adequate assessment&#xD;
        of whether we can optimize body composition in these individuals with both exercise and&#xD;
        dietary changes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 20, 2023</start_date>
    <completion_date type="Anticipated">August 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 20, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis</measure>
      <time_frame>3 months</time_frame>
      <description>Measurement on bioimpedance analysis machine (Inbody 970)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via ultrasound</measure>
      <time_frame>3 months</time_frame>
      <description>Measurement via ultrasound and calculation with Jackson-Pollack calculations</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determine changes in bone mineral concentration in pounds from before to after the nutrition and exercise regimen</measure>
      <time_frame>3 months</time_frame>
      <description>Measurement on bioimpedance analysis machine (Inbody 970)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine changes in GAD7 anxiety score from before to after the nutrition and exercise regimen</measure>
      <time_frame>3 months</time_frame>
      <description>GAD7 asks 8 questions rated from 0 to 3</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine changes in PHQ9 depression score from before to after the nutrition and exercise regimen</measure>
      <time_frame>3 months</time_frame>
      <description>PHQ9 asks 10 questions rated from 0 to 3</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen</measure>
      <time_frame>3 months</time_frame>
      <description>EQ-5D asks 5 questions rates from 1-5 and an overall rating of health</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen</measure>
      <time_frame>3 months</time_frame>
      <description>Load is calculated by multiplying sets by repetitions by weight lifted for a specific exercise</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine changes in Y-balance score for each leg</measure>
      <time_frame>3 months</time_frame>
      <description>Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen</measure>
      <time_frame>3 months</time_frame>
      <description>Functional movement screen (FMS) is a 7 movement test where an individual can score from 0 to 21</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine changes in resting metabolic rate in kilocalories/day from before to after the nutrition and exercise regimen</measure>
      <time_frame>3 months</time_frame>
      <description>Measurement via VO2 Master indirect calorimeter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine changes in muscle mass in pounds from before to after the nutrition and exercise regimen</measure>
      <time_frame>3 months</time_frame>
      <description>Measurement on bioimpedance analysis machine (Inbody 970)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Resistance training with high quality low-carbohydrate nutrition regimen</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The regimen will consist of an intense resistance training program with linear progression and the goal of increase strength, mobility, muscle mass, and functional capacity. The nutrition program will avoid calorie counting, and instead focus on quality, while maximizing protein and limiting carbohydrates.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nutrition and resistance training exercise intervention</intervention_name>
      <description>3 month 2-3 times/week, 60 min exercise regimen utilizes compound movements to focus on body composition, strength, and mobility. Classes are run by certified strength and conditioning specialists and adjusted for linear progression and safety, progressing from compound to isolated movements to maximize safety.&#xD;
  The nutrition intervention focuses on dietary quality by following a &quot;healthy low-carbohydrate&quot; diet, focusing on nutrient dense foods high and avoiding processed foods and simple carbohydrates to keep totals under 100g/day. Participants will be advised to eat vegetables, avoid snacking, cook all meals with family and friends, avoid eating on the run, and focus on whole foods that require preparation. Calculations and quantification of calories will be avoided, while protein consumption goals are 1.3-1.8 g/kg per. Dietary strategy will be continuously discussed during exercise sessions and the PI will have twice monthly meetings with participants.</description>
      <arm_group_label>Resistance training with high quality low-carbohydrate nutrition regimen</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 20-89 years&#xD;
  &#xD;
            2. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma&#xD;
               of the breast.&#xD;
  &#xD;
            3. Women must have undergone treatment for breast cancer, including one or more of the&#xD;
               following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal&#xD;
               therapy. Women undergoing active chemotherapy are not allowed on study. Treatment with&#xD;
               targeted agents and immunotherapy is allowed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any current treatment with chemotherapy for breast cancer&#xD;
  &#xD;
            2. Inability to get and down off the ground or squat body weight&#xD;
  &#xD;
            3. Inability to safely engage in group sessions&#xD;
  &#xD;
            4. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to&#xD;
               be unsafe to engage in resistance training&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Samantha Campbell</last_name>
      <phone>(412) 330-6151</phone>
      <email>samantha.campbell@ahn.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>AHN CI Exercise Oncology and Resiliency</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Colin E Champ</last_name>
        <phone>412-734-7605</phone>
        <email>colin.champ@ahn.org</email>
      </contact>
      <investigator>
        <last_name>Colin E Champ, MD, CSCS</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Christopher L Peluso, MS, CSCS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Christie Hilton, DO</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Gardner CD, Trepanowski JF, Del Gobbo LC, Hauser ME, Rigdon J, Ioannidis JPA, Desai M, King AC. Effect of Low-Fat vs Low-Carbohydrate Diet on 12-Month Weight Loss in Overweight Adults and the Association With Genotype Pattern or Insulin Secretion: The DIETFITS Randomized Clinical Trial. JAMA. 2018 Feb 20;319(7):667-679. doi: 10.1001/jama.2018.0245. Erratum In: JAMA. 2018 Apr 3;319(13):1386. JAMA. 2018 Apr 24;319(16):1728.</citation>
      <PMID>29466592</PMID>
    </reference>
    <reference>
      <citation>Champ CE, Carpenter DJ, Diaz AK, Rosenberg J, Ackerson BG, Hyde PN. Resistance Training for Patients with Cancer: A Conceptual Framework for Maximizing Strength, Power, Functional Mobility, and Body Composition to Optimize Health and Outcomes. Sports Med. 2023 Jan;53(1):75-89. doi: 10.1007/s40279-022-01759-z. Epub 2022 Sep 29.</citation>
      <PMID>36175646</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>breast cancer</keyword>
    <keyword>nutrition</keyword>
    <keyword>body composition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Undecided at this point</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978960
  org study id: 2023-131-SG
  nct id: NCT05978960
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This protocol seeks to analyze patient outcomes of the standard of care, monitored group
        exercise regimen of high-load resistance training and functional exercises with compound
        movements in conjunction with a nutrition regimen focused on food quality under close
        supervision on women who have been treated for breast cancer.
  Excess adipose tissue is a risk factor for the diagnosis of breast cancer and is also
        associated with an increased risk of disease recurrence.1 Additionally weight gain during and
        after treatment for breast cancer is associated with a higher risk of recurrence, distant
        metastases, and death.2 More specifically, low muscle mass and increased adipose tissue is
        associated with poorer outcomes after the treatment of breast cancer.3 Yet, most women gain
        significant weight during and after breast cancer treatment, potentially compromising
        outcomes.
  
        Effective methods to promote weight loss and improve metabolic and hormonal dysregulation,
        inflammation, and body composition in the breast cancer setting are urgently needed. In the
        noncancer setting, the promotion of high-quality diets that avoided processed food and simple
        carbohydrates in the DIETFITS study promoted weight loss4. However, this dietary strategy and
        others were utilized to result in weight loss, but do not necessarily consider maximizing
        body composition, i.e., muscle mass preservation or increase, and adipose tissue loss.
  
        The major, and some would consider only, non-pharmacological method to increase muscle mass
        is via resistance training with an adequate stimulus and quantity to elicit and promote
        hypertrophy.5 Our group has already shown that profound muscle hypertrophy is attainable in a
        population of women undergoing treatment for breast cancer, particularly when the dose
        threshold of load and repetitions is met. At interim analysis, this program revealed a 2 lb.
        increase in muscle mass and a 6 lb. decrease in adipose tissue after a 3 month program
        utilizing linear progression.
  
        Based on the DIEFITS protocol which has been described as a "healthy low-carbohydrate" diet,
        participants will be advised to eat nutrient dense food sources high in vitamins, minerals,
        and nutrients. Participants will be told to limit processed foods, sugar, bread, pasta, and
        other simple carbohydrates. Participants will be advised to eat plenty of colorful and
        nonstarchy vegetables. Finally, participants will be told to avoid snacking between meals,
        cook most/all meals, eat with family and friends, avoid eating food in the car or on the run,
        and focus on whole foods that require preparation. This protocol resulted in significant
        weight loss at one year. Additionally, the lack of calculations and quantification of
        calories leaves this as a more user-friendly option for participants.
  
        The exercise regimen from EXERT-BC has yet to be combined with a dietary intervention. Thus,
        the following protocol will assess our resistance training regimen in conjunction with a
        nutrition intervention similar to the DIETFITS Protocol. This will allow adequate assessment
        of whether we can optimize body composition in these individuals with both exercise and
        dietary changes.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via bioimpedance analysis
  time frame: 3 months
  description: Measurement on bioimpedance analysis machine (Inbody 970)
  measure: Determine changes in fat mass in pounds from before to after the nutrition and exercise regimen via ultrasound
  time frame: 3 months
  description: Measurement via ultrasound and calculation with Jackson-Pollack calculations
  measure: Determine changes in bone mineral concentration in pounds from before to after the nutrition and exercise regimen
  time frame: 3 months
  description: Measurement on bioimpedance analysis machine (Inbody 970)
  measure: Determine changes in GAD7 anxiety score from before to after the nutrition and exercise regimen
  time frame: 3 months
  description: GAD7 asks 8 questions rated from 0 to 3
  measure: Determine changes in PHQ9 depression score from before to after the nutrition and exercise regimen
  time frame: 3 months
  description: PHQ9 asks 10 questions rated from 0 to 3
  measure: Determine changes in EQ-5D responses 1-5 and overall score from before to after the nutrition and exercise regimen
  time frame: 3 months
  description: EQ-5D asks 5 questions rates from 1-5 and an overall rating of health
  measure: Determine changes in strength via load measured in pounds from before to after the nutrition and exercise regimen
  time frame: 3 months
  description: Load is calculated by multiplying sets by repetitions by weight lifted for a specific exercise
  measure: Determine changes in Y-balance score for each leg
  time frame: 3 months
  description: Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk.
  measure: Determine changes in overall score of functional movement screen (FMS) from before to after the nutrition and exercise regimen
  time frame: 3 months
  description: Functional movement screen (FMS) is a 7 movement test where an individual can score from 0 to 21
  measure: Determine changes in resting metabolic rate in kilocalories/day from before to after the nutrition and exercise regimen
  time frame: 3 months
  description: Measurement via VO2 Master indirect calorimeter
  measure: Determine changes in muscle mass in pounds from before to after the nutrition and exercise regimen
  time frame: 3 months
  description: Measurement on bioimpedance analysis machine (Inbody 970)
  arm group label: Resistance training with high quality low-carbohydrate nutrition regimen
  arm group type: Experimental
  description: The regimen will consist of an intense resistance training program with linear progression and the goal of increase strength, mobility, muscle mass, and functional capacity. The nutrition program will avoid calorie counting, and instead focus on quality, while maximizing protein and limiting carbohydrates.
  intervention type: Other
  intervention name: Nutrition and resistance training exercise intervention
  description: 3 month 2-3 times/week, 60 min exercise regimen utilizes compound movements to focus on body composition, strength, and mobility. Classes are run by certified strength and conditioning specialists and adjusted for linear progression and safety, progressing from compound to isolated movements to maximize safety.
  The nutrition intervention focuses on dietary quality by following a "healthy low-carbohydrate" diet, focusing on nutrient dense foods high and avoiding processed foods and simple carbohydrates to keep totals under 100g/day. Participants will be advised to eat vegetables, avoid snacking, cook all meals with family and friends, avoid eating on the run, and focus on whole foods that require preparation. Calculations and quantification of calories will be avoided, while protein consumption goals are 1.3-1.8 g/kg per. Dietary strategy will be continuously discussed during exercise sessions and the PI will have twice monthly meetings with participants.
  arm group label: Resistance training with high quality low-carbohydrate nutrition regimen
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 89 Years
  healthy volunteers: No
  last name: Samantha Campbell
  phone: (412) 330-6151
  email: samantha.campbell@ahn.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  citation: Gardner CD, Trepanowski JF, Del Gobbo LC, Hauser ME, Rigdon J, Ioannidis JPA, Desai M, King AC. Effect of Low-Fat vs Low-Carbohydrate Diet on 12-Month Weight Loss in Overweight Adults and the Association With Genotype Pattern or Insulin Secretion: The DIETFITS Randomized Clinical Trial. JAMA. 2018 Feb 20;319(7):667-679. doi: 10.1001/jama.2018.0245. Erratum In: JAMA. 2018 Apr 3;319(13):1386. JAMA. 2018 Apr 24;319(16):1728.
  PMID: 29466592
  citation: Champ CE, Carpenter DJ, Diaz AK, Rosenberg J, Ackerson BG, Hyde PN. Resistance Training for Patients with Cancer: A Conceptual Framework for Maximizing Strength, Power, Functional Mobility, and Body Composition to Optimize Health and Outcomes. Sports Med. 2023 Jan;53(1):75-89. doi: 10.1007/s40279-022-01759-z. Epub 2022 Sep 29.
  PMID: 36175646
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No
  ipd description: Undecided at this point