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/NCT06018038</url>
    </required_header>
    <id_info>
      <org_study_id>GO 23/489</org_study_id>
      <nct_id>NCT06018038</nct_id>
    </id_info>
    <brief_title>Arm Exercise Capacity and Maximal Oxygen Consumption With Breast Cancer</brief_title>
    <official_title>A Comparison of Upper Extremity Exercise Capacity, Maximum Oxygen Consumption, Daily Activities, and Physical Activity Level in Breast Cancer and Healthy Individuals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hacettepe University</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>
        Breast cancer is the most common type of cancer among women worldwide. The incidence rate has&#xD;
        reached approximately 16%. According to 2016 data from the Ministry of Health, the incidence&#xD;
        of breast cancer in Turkey is 46.8 per 100,000 people and approximately 17,000 women are&#xD;
        diagnosed with breast cancer each year. While breast cancer survival rate is 80% in developed&#xD;
        countries, this rate varies between 40-60% in low-middle income countries. Survival can be&#xD;
        increased with early diagnosis and more effective treatment methods. However, a wide range of&#xD;
        treatment-related complications are observed during and/or after breast cancer treatment.&#xD;
        Cancer survivors are exposed to a variety of direct (local/regional therapy, systemic therapy&#xD;
        and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that&#xD;
        can have adverse effects on pulmonary, cardiovascular, hematologic and musculoskeletal&#xD;
        components. Oxygen consumption in cancer patients may be adversely affected by aging,&#xD;
        deconditioning, existing comorbidities, cancer pathophysiology and cancer treatments&#xD;
        (surgery, radiation, chemotherapy and hormone therapy). Although decreased functional&#xD;
        capacity is common after breast cancer treatment, there are few studies evaluating maximal&#xD;
        arm exercise capacity with oxygen consumption.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In recent years, thanks to the increasing treatment possibilities with the developing&#xD;
        technology, the majority of patients show good functional recovery after breast cancer.&#xD;
        However, it has been reported that the treatments negatively affect the functional capacity&#xD;
        of the upper extremities, daily life, work and social activities and reduce the quality of&#xD;
        life. It has also been reported that breast cancer-related lymphedema (BCRL) may both cause&#xD;
        and exacerbate treatment-related complications such as decreased functional capacity of the&#xD;
        upper extremities and worsened quality of life after breast cancer treatments. In addition,&#xD;
        it has been found that lymphedema decreases the muscle strength and range of motion of the&#xD;
        limb in which it develops and causes an increase in symptoms such as pain, fatigue and&#xD;
        discomfort. These complications caused by lymphedema lead to decreased functional level of&#xD;
        the upper extremity, activity limitations and decreased quality of life. Cardiovascular&#xD;
        health is negatively affected after breast cancer. Decreased cardiorespiratory performance&#xD;
        also has direct consequences on daily task performance and therefore quality of life is&#xD;
        negatively affected.&#xD;
  &#xD;
        The gold standard method of measuring cardiorespiratory exercise capacity is cardiopulmonary&#xD;
        exercise testing (CPET). This method determines the causes of limitation during exercise and&#xD;
        gives maximal oxygen consumption (VO2max) as a measure of maximum performance. In cancer&#xD;
        patients, the oxygen system may be adversely affected by chemotherapy. Effects of&#xD;
        chemotherapeutic agents on respiratory, cardiac, blood, vascular or skeletal muscle functions&#xD;
        have been observed, potentially contributing to impaired cardiorespiratory fitness.&#xD;
        Cardiorespiratory function is not routinely measured at any stage of breast cancer treatment&#xD;
        and CPET is rarely used in clinical settings. Although low VO2max measurements have been&#xD;
        observed in intervention studies during breast cancer survivorship and these studies were&#xD;
        conducted without the use of an arm ergometer, to our knowledge, there is very limited&#xD;
        information on the impact of cancer treatment on cardiorespiratory fitness using gold&#xD;
        standard testing methods.&#xD;
  &#xD;
        Although decreased functional capacity is common after breast cancer treatment, there are few&#xD;
        studies evaluating maximal arm exercise capacity with oxygen consumption.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cardiopulmonary Exercise Testing (CPET)</measure>
      <time_frame>One Year</time_frame>
      <description>Maximal Oxygen Consumption (VO2max)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Upper Extremity Oxidative Muscle Metabolism</measure>
      <time_frame>One Year</time_frame>
      <description>Muscle Oxygen Saturation (SmO2 )</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral Muscle Strength</measure>
      <time_frame>One Year</time_frame>
      <description>Hand grip strength by hand dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of Quality of Life</measure>
      <time_frame>One Year</time_frame>
      <description>European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) All scores were linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity levels</measure>
      <time_frame>One Year</time_frame>
      <description>The International Physical Activity Questionnaire - Short Form (IPAQ-SF) The physical activity status of participants was grouped as follows: (a) inactive [≤600 metabolic equivalent MET)-min/week]; (b) minimum active (&gt;600 up to ≤3000 MET-min/week); and (c) active (&gt;3000 MET-min/week)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Upper Limb Functionality</measure>
      <time_frame>One Year</time_frame>
      <description>Upper Limb Functional Test (ULIFT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Assessment</measure>
      <time_frame>One Year</time_frame>
      <description>McGill Pain Scale McGill pain scale determines the severity of pain and is divided into zero, which means no pain, and 10, which means severe pain;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue Measurement</measure>
      <time_frame>One Year</time_frame>
      <description>Piper Fatigue Scale (PFS) Responses for each item It is evaluated between 0-10 points. The total fatigue score is based on 22 items scores are summed and divided by the number of items. Scale obtained from high scores indicate a high level of perceived fatigue shows.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>anthropometric measurements</measure>
      <time_frame>One Year</time_frame>
      <description>Arm Circumference</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Upper Extremity</condition>
    <condition>Oxygen Consumption</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Breast Cancer Group</arm_group_label>
      <description>Inclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e. surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <description>The inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Maximal Exercise Capacity, Maximal Oxygen Consumption (VO2max)</intervention_name>
      <description>Cardiopulmonary Exercise Testing (CPET)</description>
      <arm_group_label>Breast Cancer Group</arm_group_label>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients between the ages of 18-65 years who are diagnosed with breast cancer at Hacettepe&#xD;
          University Hospital, Department of Internal Medicine, Division of Medical Oncology, and who&#xD;
          volunteer to participate in the study will be included in the study. For healthy groups,&#xD;
          age and gender appropriate volunteers will be recruited for the study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Breast Cancer Group:&#xD;
  &#xD;
            1. Being between 18-65 years of age,&#xD;
  &#xD;
            2. Volunteering to participate in the research,&#xD;
  &#xD;
            3. Stage I-III breast cancer,&#xD;
  &#xD;
            4. At least 15 months after breast cancer surgery,&#xD;
  &#xD;
            5. Six months after active breast cancer treatment (i.e. surgery/chemotherapy),&#xD;
  &#xD;
            6. No problems in reading and/or understanding the scales and being able to cooperate&#xD;
               with the tests,&#xD;
  &#xD;
          Healthy group:&#xD;
  &#xD;
            1. Age between 18-65 years,&#xD;
  &#xD;
            2. Volunteering to participate in the research,&#xD;
  &#xD;
            3. No problems in reading and/or understanding the scales and being able to cooperate&#xD;
               with the tests.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Breast Cancer Group:&#xD;
  &#xD;
            1. Presence of active infection,&#xD;
  &#xD;
            2. Musculoskeletal and neurological diseases that may affect exercise performance,&#xD;
               symptomatic heart disease,&#xD;
  &#xD;
            3. Having a neurological disease or other clinical diagnosis that may affect cognitive&#xD;
               status.&#xD;
  &#xD;
          Healthy group:&#xD;
  &#xD;
            1. Having any orthopedic or neuromuscular condition that would interfere with walking or&#xD;
               exercise performance,&#xD;
  &#xD;
            2. Having any chronic disease or psychiatric disorders or mental impairments that may&#xD;
               interfere with cooperation or compliance with exercise tests&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ebru Calik Kutukcu, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Melda Saglam, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ebru Calik Kutukcu, PhD</last_name>
      <phone>+903123051576</phone>
      <phone_ext>195</phone_ext>
      <email>ebru.calik@hacettepe.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Naciye Vardar-Yagli, PhD</last_name>
      <phone>+03123051576</phone>
      <phone_ext>129</phone_ext>
      <email>naciyevardar@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hacettepe University</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Ebru Calik Kutukcu</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Maximal Oxygen Consumption</keyword>
    <keyword>breast cancer</keyword>
    <keyword>Upper Extremity Exercise Capacity</keyword>
    <keyword>Physical Activity Level</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>
  
  
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/NCT06018038
  org study id: GO 23/489
  nct id: NCT06018038
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer is the most common type of cancer among women worldwide. The incidence rate has
        reached approximately 16%. According to 2016 data from the Ministry of Health, the incidence
        of breast cancer in Turkey is 46.8 per 100,000 people and approximately 17,000 women are
        diagnosed with breast cancer each year. While breast cancer survival rate is 80% in developed
        countries, this rate varies between 40-60% in low-middle income countries. Survival can be
        increased with early diagnosis and more effective treatment methods. However, a wide range of
        treatment-related complications are observed during and/or after breast cancer treatment.
        Cancer survivors are exposed to a variety of direct (local/regional therapy, systemic therapy
        and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that
        can have adverse effects on pulmonary, cardiovascular, hematologic and musculoskeletal
        components. Oxygen consumption in cancer patients may be adversely affected by aging,
        deconditioning, existing comorbidities, cancer pathophysiology and cancer treatments
        (surgery, radiation, chemotherapy and hormone therapy). Although decreased functional
        capacity is common after breast cancer treatment, there are few studies evaluating maximal
        arm exercise capacity with oxygen consumption.
  In recent years, thanks to the increasing treatment possibilities with the developing
        technology, the majority of patients show good functional recovery after breast cancer.
        However, it has been reported that the treatments negatively affect the functional capacity
        of the upper extremities, daily life, work and social activities and reduce the quality of
        life. It has also been reported that breast cancer-related lymphedema (BCRL) may both cause
        and exacerbate treatment-related complications such as decreased functional capacity of the
        upper extremities and worsened quality of life after breast cancer treatments. In addition,
        it has been found that lymphedema decreases the muscle strength and range of motion of the
        limb in which it develops and causes an increase in symptoms such as pain, fatigue and
        discomfort. These complications caused by lymphedema lead to decreased functional level of
        the upper extremity, activity limitations and decreased quality of life. Cardiovascular
        health is negatively affected after breast cancer. Decreased cardiorespiratory performance
        also has direct consequences on daily task performance and therefore quality of life is
        negatively affected.
  
        The gold standard method of measuring cardiorespiratory exercise capacity is cardiopulmonary
        exercise testing (CPET). This method determines the causes of limitation during exercise and
        gives maximal oxygen consumption (VO2max) as a measure of maximum performance. In cancer
        patients, the oxygen system may be adversely affected by chemotherapy. Effects of
        chemotherapeutic agents on respiratory, cardiac, blood, vascular or skeletal muscle functions
        have been observed, potentially contributing to impaired cardiorespiratory fitness.
        Cardiorespiratory function is not routinely measured at any stage of breast cancer treatment
        and CPET is rarely used in clinical settings. Although low VO2max measurements have been
        observed in intervention studies during breast cancer survivorship and these studies were
        conducted without the use of an arm ergometer, to our knowledge, there is very limited
        information on the impact of cancer treatment on cardiorespiratory fitness using gold
        standard testing methods.
  
        Although decreased functional capacity is common after breast cancer treatment, there are few
        studies evaluating maximal arm exercise capacity with oxygen consumption.
  observational model: Other
  time perspective: Prospective
  measure: Cardiopulmonary Exercise Testing (CPET)
  time frame: One Year
  description: Maximal Oxygen Consumption (VO2max)
  measure: Upper Extremity Oxidative Muscle Metabolism
  time frame: One Year
  description: Muscle Oxygen Saturation (SmO2 )
  measure: Peripheral Muscle Strength
  time frame: One Year
  description: Hand grip strength by hand dynamometer
  measure: Evaluation of Quality of Life
  time frame: One Year
  description: European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) All scores were linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score
  measure: Physical activity levels
  time frame: One Year
  description: The International Physical Activity Questionnaire - Short Form (IPAQ-SF) The physical activity status of participants was grouped as follows: (a) inactive [≤600 metabolic equivalent MET)-min/week]; (b) minimum active (>600 up to ≤3000 MET-min/week); and (c) active (>3000 MET-min/week)
  measure: Upper Limb Functionality
  time frame: One Year
  description: Upper Limb Functional Test (ULIFT)
  measure: Pain Assessment
  time frame: One Year
  description: McGill Pain Scale McGill pain scale determines the severity of pain and is divided into zero, which means no pain, and 10, which means severe pain;
  measure: Fatigue Measurement
  time frame: One Year
  description: Piper Fatigue Scale (PFS) Responses for each item It is evaluated between 0-10 points. The total fatigue score is based on 22 items scores are summed and divided by the number of items. Scale obtained from high scores indicate a high level of perceived fatigue shows.
  measure: anthropometric measurements
  time frame: One Year
  description: Arm Circumference
  arm group label: Breast Cancer Group
  description: Inclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e. surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status.
  arm group label: Control Group
  description: The inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests.
  intervention type: Diagnostic Test
  intervention name: Maximal Exercise Capacity, Maximal Oxygen Consumption (VO2max)
  description: Cardiopulmonary Exercise Testing (CPET)
  arm group label: Breast Cancer Group
  arm group label: Control Group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 15 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ebru Calik Kutukcu, PhD
  role: Principal Investigator
  affiliation: Hacettepe University
  last name: Melda Saglam, PhD
  role: Study Chair
  affiliation: Hacettepe University
  last name: Ebru Calik Kutukcu, PhD
  phone: +903123051576
  phone ext: 195
  email: ebru.calik@hacettepe.edu.tr
  last name: Naciye Vardar-Yagli, PhD
  phone: +03123051576
  phone ext: 129
  email: naciyevardar@yahoo.com
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Ebru Calik Kutukcu
  investigator title: Associate Professor
  mesh term: Breast Neoplasms
  sharing ipd: No