<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/NCT04500080</url>
  </required_header>
  <id_info>
    <org_study_id>520/2020/SPER/IRCCSRE</org_study_id>
    <nct_id>NCT04500080</nct_id>
  </id_info>
  <brief_title>Feasibility and Safety of Physical Exercise in Men With Prostate Cancer</brief_title>
  <acronym>PCa_Ex</acronym>
  <official_title>Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Unità Sanitaria Locale Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondazione Manodori di Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Modena and Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Unità Sanitaria Locale Reggio Emilia</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>
      Prostate cancer (PCa) is among the most widespread in the male population and represents 19%&#xD;
      of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT)&#xD;
      and Radiotherapy (RT) are used for increase survival. However, both therapies are associated&#xD;
      with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive&#xD;
      decline that together lead to an increase risk of accidental falls and fractures.&#xD;
&#xD;
      Guidelines for cancer survivors recommend Physical Exercise (PE) as a strategy to reduce&#xD;
      several side effects of therapies. However, most people living with cancer do not meet&#xD;
      current exercise recommendations.&#xD;
&#xD;
      Indeed, an effective PE program requires the application of long-term, moderate to high&#xD;
      intensity activity. Thus it may be difficult to implement this type of recommendation in&#xD;
      patient with PCa.&#xD;
&#xD;
      Therefore, this study aims to develop an experimental PE intervention testing their&#xD;
      feasibility and safety and the patients' satisfaction, aimed at improving the health&#xD;
      conditions of the patients with PCa receiving ADT and RT. Furthermore, long-term falls and&#xD;
      fracture events will be monitored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of&#xD;
      a structured, multicomponent, supervised and unsupervised exercise program.&#xD;
&#xD;
      Secondary outcome will be evaluate the change in the health condition, in particular muscle&#xD;
      strength, cognitive function, fatigue, balance, anxiety and depression level, and quality of&#xD;
      life.&#xD;
&#xD;
      The PE program will be conducted at the &quot;Virgilio Camparada&quot; Municipal Athletic Track in the&#xD;
      city of Reggio Emilia (IT). Patients will be participate in a supervised exercise program&#xD;
      with three sessions per week, for eight weeks. Subsequently, the intervention will continue&#xD;
      further for four weeks maintaining one supervised session and two unsupervised sessions a&#xD;
      week. Finally, sessions will be performed without supervision for further eight weeks. The&#xD;
      overall duration of the intervention will be twenty weeks. In addition, an evaluation will be&#xD;
      performed at one year from baseline to monitor long-term fall and fracture events.&#xD;
&#xD;
      At baseline will be the following assessment:&#xD;
&#xD;
      - clinical and anthropometric data and the Six Minute Walking Test (6MWT) to determine the&#xD;
      intensity of aerobic exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 14, 2020</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</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>
    <intervention_model_description>Feasibility pilot study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility - Recruitment rate</measure>
    <time_frame>At baseline (T0)</time_frame>
    <description>Percentage ratio between patients included in the study and number of participants screened for recruitment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - Adherence rate to the exercise program</measure>
    <time_frame>Throughout the 20 week study period</time_frame>
    <description>Determine the percentage of patients adhering to the program and the weekly exercise sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - Dropout rate</measure>
    <time_frame>Throughout the 20 week study period</time_frame>
    <description>Percentage of patients that withdraw from the study and the reason to withdraw</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - Safety/Adverse events</measure>
    <time_frame>Throughout the 20 week study period</time_frame>
    <description>Any adverse events, related or not related to the exercise program, will be documented</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility - Compliance and patients' experience</measure>
    <time_frame>Following the study conclusion at 20 weeks.</time_frame>
    <description>Determined by qualitative evaluation, using interviews, to assess experiences, accessibility and acceptability of the exercise intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of muscular strength assessment</measure>
    <time_frame>At baseline and 20 weeks.</time_frame>
    <description>Lower body muscle strength will be determined with the 10-repetitions maximum test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of cognitive status assessment</measure>
    <time_frame>At baseline and 20 weeks.</time_frame>
    <description>Cognitive status will be assess using the Mini Mental State Examination (MMSE), a 30-point questionnaire italian version. A score of 24 or more (out of 30) indicates a normal cognition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of fatigue assessment</measure>
    <time_frame>At baseline and 20 weeks.</time_frame>
    <description>Fatigue will be measured using the Fatigue Severity Scale (FSS). FSS is a 9-item questionnaire on how fatigue interferes activities and rates its severity. The item are scored on a 7 point scale with 1 = strongly disagree and 7 = strongly agree. The minimum score = 9, maximum score = 63. Higher score means greater fatigue severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of fall risk assessment</measure>
    <time_frame>At baseline and 20 weeks.</time_frame>
    <description>Fall risk will be assessed using the Tinetti Performance Oriented Mobility Assessment (POMA). The Tinetti POMA is a clinical test used to measure balance and gait abilities. The balance section (POMA-B) consists of 9 items while the gait section (POMA-G) consists of 8 items.Each of these items has answer choices that are weighted on an ordinal scale from 0 to 1 or 2. &quot;0&quot; indicates the highest level of impairment and &quot;2&quot; the individuals independence. The maximum possible total score for POMA-T is 28, for POMA-B is 16, and for POMA-G is 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of anxiety and depression level</measure>
    <time_frame>At baseline and 20 weeks.</time_frame>
    <description>Depression and anxiety level will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale, seven relate to anxiety and seven relate to depression. The total score goes from 0-21. Higher total scores indicate greater levels of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of quality of life assessment</measure>
    <time_frame>At baseline and 20 weeks.</time_frame>
    <description>Quality of life will be measured by a Short form-12 questionnaire (SF-12). The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Higher scores indicate a better physical and mental health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls and fractures.</measure>
    <time_frame>Throughout the 20 week study period and at one year of follow-up.</time_frame>
    <description>Registration of number of falls and fractures events through patient interview.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Androgen Deprivation Therapy</condition>
  <condition>Radiotherapy</condition>
  <arm_group>
    <arm_group_label>PE intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic, resistance, and neuromotor exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PE Intervention</intervention_name>
    <description>Each single exercise session will last for one hour and will consist of a combination of the following elements:&#xD;
Aerobic Exercise (AE): 20-30 minutes at moderate-high intensity, from 60 to 80% of the maximum heart rate (% HRmax).&#xD;
Resistance Exercise (RE): 30 minutes of strength activity of the major muscle groups.&#xD;
Neuromotor Exercise (NE): will be integrated with strength exercises and will consist of jumping, balance and coordination activities</description>
    <arm_group_label>PE intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically documented diagnosis of PCa;&#xD;
&#xD;
          -  Undergo ADT and RT during the study period;&#xD;
&#xD;
          -  At least 18 years old;&#xD;
&#xD;
          -  Willing and able to give written informed consent;&#xD;
&#xD;
          -  Able to read and understand Italian Language;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculoskeletal, cardiovascular, neurological or psychiatric disorders that&#xD;
             contraindicate participation in an exercise program.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefania Costi, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda USL-IRCCS di Reggio Emilia</name>
      <address>
        <city>Reggio Emilia</city>
        <state>Emilia-Romagna</state>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Winters-Stone KM, Moe E, Graff JN, Dieckmann NF, Stoyles S, Borsch C, Alumkal JJ, Amling CL, Beer TM. Falls and Frailty in Prostate Cancer Survivors: Current, Past, and Never Users of Androgen Deprivation Therapy. J Am Geriatr Soc. 2017 Jul;65(7):1414-1419. doi: 10.1111/jgs.14795. Epub 2017 Mar 6.</citation>
    <PMID>28263373</PMID>
  </results_reference>
  <results_reference>
    <citation>Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195.</citation>
    <PMID>20559064</PMID>
  </results_reference>
  <results_reference>
    <citation>Feng LR, Espina A, Saligan LN. Association of Fatigue Intensification with Cognitive Impairment during Radiation Therapy for Prostate Cancer. Oncology. 2018;94(6):363-372. doi: 10.1159/000487081. Epub 2018 Mar 7.</citation>
    <PMID>29514170</PMID>
  </results_reference>
  <results_reference>
    <citation>Gardner JR, Livingston PM, Fraser SF. Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. J Clin Oncol. 2014 Feb 1;32(4):335-46. doi: 10.1200/JCO.2013.49.5523. Epub 2013 Dec 16.</citation>
    <PMID>24344218</PMID>
  </results_reference>
  <results_reference>
    <citation>Bourke L, Smith D, Steed L, Hooper R, Carter A, Catto J, Albertsen PC, Tombal B, Payne HA, Rosario DJ. Exercise for Men with Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2016 Apr;69(4):693-703. doi: 10.1016/j.eururo.2015.10.047. Epub 2015 Nov 26.</citation>
    <PMID>26632144</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Feasibility</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT04500080
org study id: 520/2020/SPER/IRCCSRE
nct id: NCT04500080
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prostate cancer (PCa) is among the most widespread in the male population and represents 19%
      of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT)
      and Radiotherapy (RT) are used for increase survival. However, both therapies are associated
      with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive
      decline that together lead to an increase risk of accidental falls and fractures.

      Guidelines for cancer survivors recommend Physical Exercise (PE) as a strategy to reduce
      several side effects of therapies. However, most people living with cancer do not meet
      current exercise recommendations.

      Indeed, an effective PE program requires the application of long-term, moderate to high
      intensity activity. Thus it may be difficult to implement this type of recommendation in
      patient with PCa.

      Therefore, this study aims to develop an experimental PE intervention testing their
      feasibility and safety and the patients' satisfaction, aimed at improving the health
      conditions of the patients with PCa receiving ADT and RT. Furthermore, long-term falls and
      fracture events will be monitored.
The non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of
      a structured, multicomponent, supervised and unsupervised exercise program.

      Secondary outcome will be evaluate the change in the health condition, in particular muscle
      strength, cognitive function, fatigue, balance, anxiety and depression level, and quality of
      life.

      The PE program will be conducted at the "Virgilio Camparada" Municipal Athletic Track in the
      city of Reggio Emilia (IT). Patients will be participate in a supervised exercise program
      with three sessions per week, for eight weeks. Subsequently, the intervention will continue
      further for four weeks maintaining one supervised session and two unsupervised sessions a
      week. Finally, sessions will be performed without supervision for further eight weeks. The
      overall duration of the intervention will be twenty weeks. In addition, an evaluation will be
      performed at one year from baseline to monitor long-term fall and fracture events.

      At baseline will be the following assessment:

      - clinical and anthropometric data and the Six Minute Walking Test (6MWT) to determine the
      intensity of aerobic exercise.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Feasibility pilot study
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility - Recruitment rate
time frame: At baseline (T0)
description: Percentage ratio between patients included in the study and number of participants screened for recruitment.
measure: Feasibility - Adherence rate to the exercise program
time frame: Throughout the 20 week study period
description: Determine the percentage of patients adhering to the program and the weekly exercise sessions.
measure: Feasibility - Dropout rate
time frame: Throughout the 20 week study period
description: Percentage of patients that withdraw from the study and the reason to withdraw
measure: Feasibility - Safety/Adverse events
time frame: Throughout the 20 week study period
description: Any adverse events, related or not related to the exercise program, will be documented
measure: Feasibility - Compliance and patients' experience
time frame: Following the study conclusion at 20 weeks.
description: Determined by qualitative evaluation, using interviews, to assess experiences, accessibility and acceptability of the exercise intervention.
measure: Change of muscular strength assessment
time frame: At baseline and 20 weeks.
description: Lower body muscle strength will be determined with the 10-repetitions maximum test.
measure: Change of cognitive status assessment
time frame: At baseline and 20 weeks.
description: Cognitive status will be assess using the Mini Mental State Examination (MMSE), a 30-point questionnaire italian version. A score of 24 or more (out of 30) indicates a normal cognition.
measure: Change of fatigue assessment
time frame: At baseline and 20 weeks.
description: Fatigue will be measured using the Fatigue Severity Scale (FSS). FSS is a 9-item questionnaire on how fatigue interferes activities and rates its severity. The item are scored on a 7 point scale with 1 = strongly disagree and 7 = strongly agree. The minimum score = 9, maximum score = 63. Higher score means greater fatigue severity.
measure: Change of fall risk assessment
time frame: At baseline and 20 weeks.
description: Fall risk will be assessed using the Tinetti Performance Oriented Mobility Assessment (POMA). The Tinetti POMA is a clinical test used to measure balance and gait abilities. The balance section (POMA-B) consists of 9 items while the gait section (POMA-G) consists of 8 items.Each of these items has answer choices that are weighted on an ordinal scale from 0 to 1 or 2. "0" indicates the highest level of impairment and "2" the individuals independence. The maximum possible total score for POMA-T is 28, for POMA-B is 16, and for POMA-G is 12.
measure: Change of anxiety and depression level
time frame: At baseline and 20 weeks.
description: Depression and anxiety level will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale, seven relate to anxiety and seven relate to depression. The total score goes from 0-21. Higher total scores indicate greater levels of depression.
measure: Change of quality of life assessment
time frame: At baseline and 20 weeks.
description: Quality of life will be measured by a Short form-12 questionnaire (SF-12). The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Higher scores indicate a better physical and mental health.
measure: Falls and fractures.
time frame: Throughout the 20 week study period and at one year of follow-up.
description: Registration of number of falls and fractures events through patient interview.
arm group label: PE intervention
arm group type: Experimental
description: Aerobic, resistance, and neuromotor exercise
intervention type: Behavioral
intervention name: PE Intervention
description: Each single exercise session will last for one hour and will consist of a combination of the following elements:
Aerobic Exercise (AE): 20-30 minutes at moderate-high intensity, from 60 to 80% of the maximum heart rate (% HRmax).
Resistance Exercise (RE): 30 minutes of strength activity of the major muscle groups.
Neuromotor Exercise (NE): will be integrated with strength exercises and will consist of jumping, balance and coordination activities
arm group label: PE intervention
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefania Costi, Ph.D.
role: Principal Investigator
affiliation: Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
facility: 
country: Italy
citation: Winters-Stone KM, Moe E, Graff JN, Dieckmann NF, Stoyles S, Borsch C, Alumkal JJ, Amling CL, Beer TM. Falls and Frailty in Prostate Cancer Survivors: Current, Past, and Never Users of Androgen Deprivation Therapy. J Am Geriatr Soc. 2017 Jul;65(7):1414-1419. doi: 10.1111/jgs.14795. Epub 2017 Mar 6.
PMID: 28263373
citation: Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195.
PMID: 20559064
citation: Feng LR, Espina A, Saligan LN. Association of Fatigue Intensification with Cognitive Impairment during Radiation Therapy for Prostate Cancer. Oncology. 2018;94(6):363-372. doi: 10.1159/000487081. Epub 2018 Mar 7.
PMID: 29514170
citation: Gardner JR, Livingston PM, Fraser SF. Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. J Clin Oncol. 2014 Feb 1;32(4):335-46. doi: 10.1200/JCO.2013.49.5523. Epub 2013 Dec 16.
PMID: 24344218
citation: Bourke L, Smith D, Steed L, Hooper R, Carter A, Catto J, Albertsen PC, Tombal B, Payne HA, Rosario DJ. Exercise for Men with Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2016 Apr;69(4):693-703. doi: 10.1016/j.eururo.2015.10.047. Epub 2015 Nov 26.
PMID: 26632144
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No