<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/NCT04401189</url>
  </required_header>
  <id_info>
    <org_study_id>2016-051-000001- 1731</org_study_id>
    <nct_id>NCT04401189</nct_id>
  </id_info>
  <brief_title>The Role of Circadian Rhythms in Cancer-Related Symptoms</brief_title>
  <acronym>CHRONO</acronym>
  <official_title>The Role of Circadian Rhythms in Cancer-Related Symptoms: A Prospective Controlled Chrono-Bio-Behavioral Observation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its&#xD;
      treatment, and that circadian rhythm disruption may be an underlying pathophysiological&#xD;
      mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep&#xD;
      disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on&#xD;
      cancer survivors' quality of life, and a pressing demand for effective interventions to treat&#xD;
      CRS, there is a need for a comprehensive examination of circadian disruption related to&#xD;
      cancer and its treatment, and its association with CRS. The study will prospectively examine&#xD;
      circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from&#xD;
      prior to surgery or chemotherapy to 12 months later. A matched healthy control group will&#xD;
      serve as a comparison.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cancer related symptoms composite score change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer related symptoms composite score change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer related symptoms composite score change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circadian Activity Rhythms change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Rest/wake activity recorded with wrist actigraphy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circadian Activity Rhythms change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>Rest/wake activity recorded with wrist actigraphy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circadian Activity Rhythms change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>Rest/wake activity recorded with wrist actigraphy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circadian skin temperature change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Distal skin temperature recorded with wrist actigraphy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circadian skin temperature change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>Distal skin temperature recorded with wrist actigraphy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circadian skin temperature change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>Distal skin temperature recorded with wrist actigraphy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dim light melatonin onset change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>Melatonin based on saliva samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>Standard neuropsychological test battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functioning change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>Standard neuropsychological test battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-related fatigue change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>FACIT fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-related fatigue change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>FACIT fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-related fatigue change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>FACIT fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Objective sleep recorded with wrist actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>Objective sleep recorded with wrist actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>Objective sleep recorded with wrist actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Perceived Stress Scale (PSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>PSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>PSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Pittsburgh sleep quality index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>Pittsburgh sleep quality index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>Pittsburgh sleep quality index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Insomnia Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>Insomnia Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>Insomnia Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported cognitive functioning change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported cognitive functioning change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>FACT-Cog</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported cognitive functioning change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>FACT-Cog</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CESD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>CESD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>CESD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported quality of life change</measure>
    <time_frame>Change from baseline to time 2 (an average of 1 month)</time_frame>
    <description>Short Form 36 (SF36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported quality of life change</measure>
    <time_frame>Change from baseline to time 3 (an average of 6 months)</time_frame>
    <description>SF36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported quality of life change</measure>
    <time_frame>Change from baseline to time 4 (through study completion, an average of 1 year)</time_frame>
    <description>SF36</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Fatigue</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Sleep</condition>
  <condition>Depression</condition>
  <condition>Quality of Life</condition>
  <condition>Stress, Psychological</condition>
  <condition>Inflammation</condition>
  <condition>Circadian Rhythm Disorders</condition>
  <condition>Cancer-Related Syndrome</condition>
  <arm_group>
    <arm_group_label>Breast cancer patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva samples for melatonin. Blood samples for inflammatory cytokines.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed breast cancer patients. Controls will be healthy volunteers of cancer-free&#xD;
        women matched on age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with early breast cancer scheduled for surgery and chemotherapy (neoadjuvant&#xD;
             or adjuvant) at Aarhus University Hospital (AUH).&#xD;
&#xD;
          -  The healthy control group will consist of an age-matched sample of participants with&#xD;
             no history of cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Shift-work&#xD;
&#xD;
          -  Melatonin supplementation&#xD;
&#xD;
          -  Insufficient Danish proficiency&#xD;
&#xD;
          -  Previous cancer diagnosis except for treated non-melanoma skin cancer&#xD;
&#xD;
          -  Confounding diagnosed or suspected psychiatric or medical conditions that might&#xD;
             significantly contribute to the CRS or symptoms/diagnoses resembling them (other than&#xD;
             those caused by cancer or its treatment) such as seasonal affective disorder.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ali Amidi, PhD</last_name>
    <phone>(+45) 8716 5305</phone>
    <email>ali@psy.au.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lisa M Wu, PhD</last_name>
    <email>lisa.wu@aias.au.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Amidi, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>April 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>April 9, 2021</last_update_submitted>
  <last_update_submitted_qc>April 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Ali Amidi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Circadian rhythms disruption</keyword>
  <keyword>Cancer-related symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Chronobiology Disorders</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT04401189
org study id: 2016-051-000001- 1731
nct id: NCT04401189
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its
      treatment, and that circadian rhythm disruption may be an underlying pathophysiological
      mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep
      disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on
      cancer survivors' quality of life, and a pressing demand for effective interventions to treat
      CRS, there is a need for a comprehensive examination of circadian disruption related to
      cancer and its treatment, and its association with CRS. The study will prospectively examine
      circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from
      prior to surgery or chemotherapy to 12 months later. A matched healthy control group will
      serve as a comparison.
observational model: Case-Control
time perspective: Prospective
measure: Cancer related symptoms composite score change
time frame: Change from baseline to time 2 (an average of 1 month)
description: A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
measure: Cancer related symptoms composite score change
time frame: Change from baseline to time 3 (an average of 6 months)
description: A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
measure: Cancer related symptoms composite score change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes
measure: Circadian Activity Rhythms change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Rest/wake activity recorded with wrist actigraphy
measure: Circadian Activity Rhythms change
time frame: Change from baseline to time 3 (an average of 6 months)
description: Rest/wake activity recorded with wrist actigraphy
measure: Circadian Activity Rhythms change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: Rest/wake activity recorded with wrist actigraphy
measure: Circadian skin temperature change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Distal skin temperature recorded with wrist actigraphy
measure: Circadian skin temperature change
time frame: Change from baseline to time 3 (an average of 6 months)
description: Distal skin temperature recorded with wrist actigraphy
measure: Circadian skin temperature change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: Distal skin temperature recorded with wrist actigraphy
measure: Dim light melatonin onset change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: Melatonin based on saliva samples
measure: Cognitive functioning change
time frame: Change from baseline to time 3 (an average of 6 months)
description: Standard neuropsychological test battery
measure: Cognitive functioning change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: Standard neuropsychological test battery
measure: Cancer-related fatigue change
time frame: Change from baseline to time 2 (an average of 1 month)
description: FACIT fatigue
measure: Cancer-related fatigue change
time frame: Change from baseline to time 3 (an average of 6 months)
description: FACIT fatigue
measure: Cancer-related fatigue change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: FACIT fatigue
measure: Sleep change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Objective sleep recorded with wrist actigraphy
measure: Sleep change
time frame: Change from baseline to time 3 (an average of 6 months)
description: Objective sleep recorded with wrist actigraphy
measure: Sleep change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: Objective sleep recorded with wrist actigraphy
measure: Inflammatory markers change
time frame: Change from baseline to time 3 (an average of 6 months)
description: Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.
measure: Inflammatory markers change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.
measure: Stress change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Perceived Stress Scale (PSS)
measure: Stress change
time frame: Change from baseline to time 3 (an average of 6 months)
description: PSS
measure: Stress change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: PSS
measure: Sleep quality change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Pittsburgh sleep quality index
measure: Sleep quality change
time frame: Change from baseline to time 3 (an average of 6 months)
description: Pittsburgh sleep quality index
measure: Sleep quality change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: Pittsburgh sleep quality index
measure: Insomnia change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Insomnia Severity Index
measure: Insomnia change
time frame: Change from baseline to time 3 (an average of 6 months)
description: Insomnia Severity Index
measure: Insomnia change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: Insomnia Severity Index
measure: Self-reported cognitive functioning change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog)
measure: Self-reported cognitive functioning change
time frame: Change from baseline to time 3 (an average of 6 months)
description: FACT-Cog
measure: Self-reported cognitive functioning change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: FACT-Cog
measure: Depression change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Center for Epidemiologic Studies Depression Scale (CESD)
measure: Depression change
time frame: Change from baseline to time 3 (an average of 6 months)
description: CESD
measure: Depression change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: CESD
measure: Self-reported quality of life change
time frame: Change from baseline to time 2 (an average of 1 month)
description: Short Form 36 (SF36)
measure: Self-reported quality of life change
time frame: Change from baseline to time 3 (an average of 6 months)
description: SF36
measure: Self-reported quality of life change
time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
description: SF36
arm group label: Breast cancer patients
arm group label: Healthy controls
Saliva samples for melatonin. Blood samples for inflammatory cytokines.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ali Amidi, PhD
phone: (+45) 8716 5305
email: ali@psy.au.dk
last name: Lisa M Wu, PhD
email: lisa.wu@aias.au.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Ali Amidi
investigator title: Assistant Professor
mesh term: Neoplasms
mesh term: Chronobiology Disorders
mesh term: Inflammation
mesh term: Stress, Psychological
sharing ipd: No