<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/NCT03284567</url>
  </required_header>
  <id_info>
    <org_study_id>FFABC</org_study_id>
    <nct_id>NCT03284567</nct_id>
  </id_info>
  <brief_title>Football Fitness After Breast Cancer</brief_title>
  <acronym>FFABC</acronym>
  <official_title>A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</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>
      Late effects of breast cancer treatment are widely reported including deteriorating fitness,&#xD;
      fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise&#xD;
      interventions may ameliorate a number of these effects including fatigue, fitness and improve&#xD;
      quality of life. However only limited knowledge exists on the potential of novel&#xD;
      interventions and settings, such as sports outside the hospital setting, to improve late&#xD;
      effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study&#xD;
      is a randomized trial comparing the effects of a football training intervention with standard&#xD;
      treatment approaches on fitness, bone mineralization, body composition, muscle strength,&#xD;
      blood pressure, and patient-reported outcomes in women treated for breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</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>
    <intervention_model_description>1/3 of participants will be randomly allocated to the control group and 2/3 of participants will be randomly allocated to the Football fitness intervention group.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Personnel assessing the primary outcome is blinded for study participants group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.</measure>
    <time_frame>6 months and 12 months.</time_frame>
    <description>Incremental test to exhaustion on a cycle ergometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in whole-body fat mass from baseline to month 6 and month 12.</measure>
    <time_frame>6 months and 12 months.</time_frame>
    <description>Assessed by dual energy x-ray absorptiometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in whole-body weight from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Body weight was measured with a digital platform scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in whole-body muscle mass from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Assessed by dual energy x-ray absorptiometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in muscle strength from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Dynamic concentric muscle strength for the knee extensors (1RM).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in balance from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Single-leg flamingo balance test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in blood pressure from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Blood pressure will be measured with a digital sphygmomanometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Procollagen type I C propeptide, osteocalcin and C-terminal telopeptide will be analyzed by a chemiluminescence method using a fully automated immunoassay system (iSYS, Immunodiagnostic Systems Ltd., Boldon, England.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in cholesterol from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Blood samples will be analyzed at baseline, 6 and 12 month for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, and glycosylated hemoglobin, respectively, by automated analyzers (Cobas Fara, Roche, Neuilly sur Seine, France) using enzymatic kits (Roche Diagnostics, Mannheim, Germany, and Tosoh G7, Tosoh Europe, Tessenderlo, Belgium).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported physical activity from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Assessed by the International Physical Activity Questionnaire (IPAQ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Assessed by the supplement EORTC QLQ-BR23.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported functional level in upper extremities from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Assessed by disabilities of the arm, shoulder and hand (DASH).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported health related quality of life from baseline to month 6 and month 12.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Assessed by dual energy x-ray absorptiometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in total body and leg bone mineral content (BMC).</measure>
    <time_frame>6 month and 12 month.</time_frame>
    <description>Assessed by dual energy x-ray absorptiometry.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Breast Neoplasm Female</condition>
  <arm_group>
    <arm_group_label>Football fitness</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the intervention group will practice soccer for 52 weeks two times weekly. A soccer instructor will be in charge of all training sessions. The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.&#xD;
Training will take place on a natural grass pitch. In adverse weather conditions (i.e., &lt; 5°C or heavy rain) training will be performed indoors. Participants will be told to avoid hard tackles and other actions that carry a risk of injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Football fitness</intervention_name>
    <description>The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.&#xD;
Training will take place on a natural grass pitch. In adverse weather conditions (i.e., &lt; 5°C or heavy rain) training will be performed indoors</description>
    <arm_group_label>Football fitness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women surgically managed for breast cancer, local and regional advanced breast cancer.&#xD;
&#xD;
          -  Completion of adjuvant chemotherapy and radiation therapy.&#xD;
&#xD;
          -  Legally competent persons with ability to read and understand Danish.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
          -  Performance level 0-1 (WHO).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  WHO performance level &gt; 1.&#xD;
&#xD;
          -  Osteoporosis (T-score &lt; -2.5).&#xD;
&#xD;
          -  Known metastatic breast cancer (stage IV).&#xD;
&#xD;
          -  Women in DBCG-group I (age =&gt; 60 years, tumor =&lt; 10 mm, invasive ductal carcinoma&#xD;
             grade I, invasive lobular carcinoma grade I / II, estrogen receptor positive and HER2&#xD;
             normal).&#xD;
&#xD;
          -  Cardiovascular or pulmonary disorders (e.g., arrhythmias, ischemic heart disease,&#xD;
             unregulated high blood pressure, chronic obstructive lung disease).&#xD;
&#xD;
          -  Ongoing anticoagulant therapy (vitamin K antagonists; Marevan, Marcoumar and low&#xD;
             molecular weight heparins; Innohep, Clexane, Fragmin) for pulmonary embolism or deep&#xD;
             venous thrombosis (DVT) due to increased bleeding risk of falls and clashes with other&#xD;
             players during exercise.&#xD;
&#xD;
          -  Current or scheduled chemotherapy and radiation therapy in the intervention period (12&#xD;
             months).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Copenhagen, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Jacob Uth</investigator_full_name>
    <investigator_title>Postdoc</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Football</keyword>
  <keyword>Late effects</keyword>
  <keyword>Physical exercise</keyword>
  <keyword>Soccer training</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Bone mineralization</keyword>
  <keyword>Body composition</keyword>
  <keyword>Fitness</keyword>
  <keyword>Aerobic capacity</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>
  </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/NCT03284567
org study id: FFABC
nct id: NCT03284567
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Late effects of breast cancer treatment are widely reported including deteriorating fitness,
      fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise
      interventions may ameliorate a number of these effects including fatigue, fitness and improve
      quality of life. However only limited knowledge exists on the potential of novel
      interventions and settings, such as sports outside the hospital setting, to improve late
      effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study
      is a randomized trial comparing the effects of a football training intervention with standard
      treatment approaches on fitness, bone mineralization, body composition, muscle strength,
      blood pressure, and patient-reported outcomes in women treated for breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1/3 of participants will be randomly allocated to the control group and 2/3 of participants will be randomly allocated to the Football fitness intervention group.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Personnel assessing the primary outcome is blinded for study participants group allocation.
measure: Mean change in fitness level (maximal oxygen uptake) from baseline to month 6 and month 12.
time frame: 6 months and 12 months.
description: Incremental test to exhaustion on a cycle ergometer.
measure: Mean change in whole-body fat mass from baseline to month 6 and month 12.
time frame: 6 months and 12 months.
description: Assessed by dual energy x-ray absorptiometry.
measure: Mean change in whole-body weight from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Body weight was measured with a digital platform scale.
measure: Mean change in whole-body muscle mass from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Assessed by dual energy x-ray absorptiometry.
measure: Mean change in muscle strength from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Dynamic concentric muscle strength for the knee extensors (1RM).
measure: Mean change in balance from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Single-leg flamingo balance test.
measure: Mean change in blood pressure from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Blood pressure will be measured with a digital sphygmomanometer.
measure: Mean change in markers of bone mineral metabolism from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Procollagen type I C propeptide, osteocalcin and C-terminal telopeptide will be analyzed by a chemiluminescence method using a fully automated immunoassay system (iSYS, Immunodiagnostic Systems Ltd., Boldon, England.
measure: Mean change in cholesterol from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Blood samples will be analyzed at baseline, 6 and 12 month for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, and glycosylated hemoglobin, respectively, by automated analyzers (Cobas Fara, Roche, Neuilly sur Seine, France) using enzymatic kits (Roche Diagnostics, Mannheim, Germany, and Tosoh G7, Tosoh Europe, Tessenderlo, Belgium).
measure: Self-reported physical activity from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Assessed by the International Physical Activity Questionnaire (IPAQ).
measure: Self-reported diagnosis-specific symptoms and side-effects from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Assessed by the supplement EORTC QLQ-BR23.
measure: Self-reported health-related quality of life outcomes from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).
measure: Self-reported functional level in upper extremities from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Assessed by disabilities of the arm, shoulder and hand (DASH).
measure: Self-reported health related quality of life from baseline to month 6 and month 12.
time frame: 6 month and 12 month.
description: Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
measure: Mean change in bone mineral density (BMD) of the spine (L2-L4), Total hip and Femoral Neck.
time frame: 6 month and 12 month.
description: Assessed by dual energy x-ray absorptiometry.
measure: Mean change in total body and leg bone mineral content (BMC).
time frame: 6 month and 12 month.
description: Assessed by dual energy x-ray absorptiometry.
arm group label: Football fitness
arm group type: Active Comparator
description: Participants in the intervention group will practice soccer for 52 weeks two times weekly. A soccer instructor will be in charge of all training sessions. The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.
Training will take place on a natural grass pitch. In adverse weather conditions (i.e., < 5°C or heavy rain) training will be performed indoors. Participants will be told to avoid hard tackles and other actions that carry a risk of injury.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.
intervention type: Behavioral
intervention name: Football fitness
description: The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.
Training will take place on a natural grass pitch. In adverse weather conditions (i.e., < 5°C or heavy rain) training will be performed indoors
arm group label: Football fitness
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jacob Uth
investigator title: Postdoc
mesh term: Breast Neoplasms
sharing ipd: No