<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/NCT01686737</url>
  </required_header>
  <id_info>
    <org_study_id>2012210</org_study_id>
    <nct_id>NCT01686737</nct_id>
  </id_info>
  <brief_title>Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients</brief_title>
  <acronym>IFaB</acronym>
  <official_title>Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universität Duisburg-Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universität Duisburg-Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer is the most frequent cancer in women and is associated with profound&#xD;
      restrictions of health-related quality of life and psychosocial health. More than&#xD;
      three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While&#xD;
      exercise interventions can improve fatigue in breast cancer patients, many patients request&#xD;
      complementary treatment approaches. Therefore, this study investigates the effects of yoga in&#xD;
      women with breast cancer compared to aerobic exercise and usual care.&#xD;
&#xD;
      It is hypothesized that yoga is more effective than usual care and equally effective as&#xD;
      aerobic exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Recruitment problems&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">July 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Week 12</time_frame>
    <description>Multidimensional Fatigue Inventory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Week 36</time_frame>
    <description>Multidimensional Fatigue Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Week 12, week 36</time_frame>
    <description>Functional Assessment of Cancer Therapy - Breast</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and anxiety</measure>
    <time_frame>Week 12, week 36</time_frame>
    <description>Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Week 12, week 36</time_frame>
    <description>Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>Week 12, week 36</time_frame>
    <description>Perceived Stress Scale&#xD;
Impact of Event Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary Cortisol</measure>
    <time_frame>Week 12, week 36</time_frame>
    <description>Cortisol awakening response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>Week 0-36</time_frame>
    <description>Adverse events</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Neoplasms</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Iyengar Yoga&#xD;
12 weeks of Iyengar yoga&#xD;
2 weekly sessions of 60 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerobic exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Walking&#xD;
12 weeks of walking&#xD;
2 weekly sessions of 60 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Iyengar Yoga</intervention_name>
    <description>12 weeks of Iyengar yoga&#xD;
2 weekly sessions of 60 minutes</description>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking</intervention_name>
    <description>12 weeks of walking&#xD;
2 weekly sessions of 60 minutes</description>
    <arm_group_label>Aerobic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-metastatic invasive breast cancer&#xD;
&#xD;
          -  currently receiving adjuvant chemotherapy&#xD;
&#xD;
          -  moderate to severe chemotherapy-induced fatigue&#xD;
&#xD;
          -  physical and cognitive capacity to participate in yoga or walking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed and pharmacologically treated psychiatric disorder except depressive&#xD;
             adaptation disorder as a reaction to cancer diagnosis&#xD;
&#xD;
          -  ECOG status &gt; 1&#xD;
&#xD;
          -  prior malignancy with a disease-free survival &lt; 10 years except curatively treated&#xD;
             basalioma of the skin and carcinoma in situ of the cervix&#xD;
&#xD;
          -  prior ductal carcinoma in situ (DCIS) ot the breast&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
&#xD;
          -  regular practice of yoga or walking during the past 12 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Holger Cramer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Duisburg-Essen, Chair of Complementary and Integrative Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gustav J. Dobos, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Duisburg-Essen, Chair of Complementary and Integrative Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind</name>
      <address>
        <city>Köln</city>
        <zip>50935</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>February 4, 2013</last_update_submitted>
  <last_update_submitted_qc>February 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universität Duisburg-Essen</investigator_affiliation>
    <investigator_full_name>Holger Cramer</investigator_full_name>
    <investigator_title>Postdoctoral fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- 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/NCT01686737
org study id: 2012210
nct id: NCT01686737
lead sponsor: 
has dmc: No
Breast cancer is the most frequent cancer in women and is associated with profound
      restrictions of health-related quality of life and psychosocial health. More than
      three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While
      exercise interventions can improve fatigue in breast cancer patients, many patients request
      complementary treatment approaches. Therefore, this study investigates the effects of yoga in
      women with breast cancer compared to aerobic exercise and usual care.

      It is hypothesized that yoga is more effective than usual care and equally effective as
      aerobic exercise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fatigue
time frame: Week 12
description: Multidimensional Fatigue Inventory
measure: Fatigue
time frame: Week 36
description: Multidimensional Fatigue Inventory
measure: Health-related quality of life
time frame: Week 12, week 36
description: Functional Assessment of Cancer Therapy - Breast
measure: Depression and anxiety
time frame: Week 12, week 36
description: Hospital Anxiety and Depression Scale
measure: Sleep quality
time frame: Week 12, week 36
description: Pittsburgh Sleep Quality Index
measure: Perceived Stress
time frame: Week 12, week 36
description: Perceived Stress Scale
Impact of Event Scale
measure: Salivary Cortisol
time frame: Week 12, week 36
description: Cortisol awakening response
measure: Safety
time frame: Week 0-36
description: Adverse events
arm group label: Yoga
arm group type: Experimental
description: Iyengar Yoga
12 weeks of Iyengar yoga
2 weekly sessions of 60 minutes
arm group label: Aerobic exercise
arm group type: Active Comparator
description: Walking
12 weeks of walking
2 weekly sessions of 60 minutes
arm group label: Usual Care
arm group type: No Intervention
intervention type: Behavioral
intervention name: Iyengar Yoga
description: 12 weeks of Iyengar yoga
2 weekly sessions of 60 minutes
arm group label: Yoga
intervention type: Behavioral
intervention name: Walking
description: 12 weeks of walking
2 weekly sessions of 60 minutes
arm group label: Aerobic exercise
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Holger Cramer, PhD
role: Principal Investigator
affiliation: University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
last name: Gustav J. Dobos, MD
role: Study Director
affiliation: University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universität Duisburg-Essen
investigator full name: Holger Cramer
investigator title: Postdoctoral fellow
mesh term: Breast Neoplasms
mesh term: Fatigue