<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/NCT03798379</url>
  </required_header>
  <id_info>
    <org_study_id>09.2015.278</org_study_id>
    <nct_id>NCT03798379</nct_id>
  </id_info>
  <brief_title>Exercises for Patients Who Were Receiving Chemotherapy</brief_title>
  <official_title>The Effect of Therapeutic Exercises on Balance, Quality of Life and Pain in Patients Who Were Receiving Neurotoxic Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hitit University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hitit 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>
      To evaluate the effect of lower extremity strengthening and balance exercises on balance,&#xD;
      quality of life and neuropathic pain of the cancer patients receiving neurotoxic&#xD;
      chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer-related mortality rates decreased considerably thanks to novel treatment methods and&#xD;
      new agents over the last two decades. Although chemotherapy (CT) is an effective treatment&#xD;
      type in reducing the size of the tumor and eliminating metastases, it may harm many different&#xD;
      organs and systems due to short &amp; long-term side effects. Peripheral neuropathy (PN) is&#xD;
      regarded as a neurological and clinical side effect for cancer patients. PN may arise as a&#xD;
      paraneoplastic symptom but more commonly occurs with neurotoxic CT agents. Short &amp; long-term&#xD;
      side effects that may damage sensory, motor, and autonomic neurons. This damage to the&#xD;
      small-fiber sensory nerves causes a change in the sense of touch, pain, and warmth, while the&#xD;
      damage to the large-fiber nerves causes a change in the sense of vibration and&#xD;
      proprioception. Motor nerve damage affects voluntary movement, muscle tone, and coordination,&#xD;
      and damage to the autonomic nervous system affects intestinal motility and blood pressure&#xD;
      over smooth muscles. Despite the fact that studies on PN treatment have generally focused on&#xD;
      pharmacological agents reducing pain or treating selected side effects, no agent that may be&#xD;
      preventive for chemotherapy induced Peripheral Neuropathy (CIPN) due to neurotoxic&#xD;
      chemotherapy has been recommended in the review of the American Society of Clinical Oncology.&#xD;
&#xD;
      Side effects due to CT such as anorexia, nausea, vomiting, mucositis, diarrhea, anemia or PN&#xD;
      may lead to impairment in the quality of life of the patient and may significantly reduce the&#xD;
      level of physical activity. Neurotoxic and ototoxic effects may cause ataxia, paresthesia and&#xD;
      dysesthesia, leading to gait, and balance disorders. CIPN has been associated with balance&#xD;
      disorder, loss of function and reduced quality of life in the literature. It may result in&#xD;
      loss of balance, difficulty in ambulation, increase in the frequency of collapse and&#xD;
      accordingly increase in injuries. Despite the fact that medical treatments used in CIPN are&#xD;
      often helpful in the treatment of neuropathic pain, no effect has been observed on muscle&#xD;
      strength, gait, and balance. It is believed that muscle strength and balance exercises, such&#xD;
      as aerobic exercises, can provide mitochondria with oxygen and glucose by increasing blood&#xD;
      supply, thereby contributing to energy production and reducing symptoms. Current data suggest&#xD;
      that exercise is applicable, safe, and beneficial for this group of patients. Balance&#xD;
      exercises at an early stage may prevent or delay the onset of sensory and motor symptoms.&#xD;
      Although exercise is accepted as a supportive treatment, which should be addressed more&#xD;
      seriously for a patient population with PN, there is not enough information in the literature&#xD;
      on timing, frequency, and mode of administration of the treatment program that will be&#xD;
      carried out in this specific group of patients.&#xD;
&#xD;
      The aim of this study is to investigate the effects of therapeutic exercise program including&#xD;
      concurrently initiated strengthening, balance and aerobic exercises on the symptoms, balance&#xD;
      status and quality of life of the group of patients who have a limited physical activity, a&#xD;
      risk of developing PN following the treatment, and will have a long-term bed rest and compare&#xD;
      with the group of patients not receiving any exercise program in the same treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">November 1, 2016</completion_date>
  <primary_completion_date type="Actual">July 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Non randomized, single blind, prospective</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Balance assessment</measure>
    <time_frame>3 months</time_frame>
    <description>NeuroCom Balance Master® device (Natus Medical, San Carlos, California, USA) is a balance evaluation device measuring the position of the center of gravity, postural control along with static and dynamic stability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg balance scale</measure>
    <time_frame>3 months</time_frame>
    <description>Berg balance scale used in the evaluation of balance based on performance is a 14-item measure in which patient is required to perform different activities.14 different activities are scored between 0 (worst) and 4 (best) according to the patient's performance. The maximum score is 56. A total score close to 56 indicates that the balance of patient is good.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PainDETECT: questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>The presence of neuropathic pain was evaluated with the painDETECT questionnaire. The maximum score is 35 and a high score indicates the severity of neuropathic pain. When the PD-Q score is more than 13, it is indicated the presence of neuropathic pain component.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>It is a questionnaire developed by the European Organization for Research and Treatment of Cancer and used to assess the quality of life of cancer patients participating in clinical trials and includes a variety of components. Patients' higher points of functional scale and general health status scale and lower points of symptom scale scores indicate a high QoL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eligible patients who were planned to receive neurotoxic chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients eligible for the study and received the 3rd cycle of chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Strengthening, balance and aerobic exercises were explained to the patients examined before chemotherapy sessions and demonstrated by applying on the patient.</description>
    <arm_group_label>Exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the ability to understand the informed consent form, and the signing the informed&#xD;
             consent form after being informed in detail,&#xD;
&#xD;
          -  planned to have ≥3 cycles of neurotoxic chemotherapy (paclitaxel, docetaxel from&#xD;
             taxane class agents, and cisplatin, oxaliplatin or carboplatin from platin group),&#xD;
&#xD;
          -  expected to have a survival of ≥6 months,&#xD;
&#xD;
          -  to have an Eastern Cooperative Oncology Group performance level between 0-2,&#xD;
&#xD;
          -  to have a full manual muscle strength.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously diagnosed peripheral neuropathy (Diabetic peripheral neuropathy, entrapment&#xD;
             neuropathies etc.)&#xD;
&#xD;
          -  Patients receiving medical treatment due to neuropathic pain (pregabalin, gabapentin,&#xD;
             duloxetine etc.)&#xD;
&#xD;
          -  Pre-existing neurological disease&#xD;
&#xD;
          -  Pre-existing diabetes mellitus (&gt;3 years or insulin use)&#xD;
&#xD;
          -  Alcoholism&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Presence of peripheral vascular disease&#xD;
&#xD;
          -  Vitamin D or vitamin B12 deficiency&#xD;
&#xD;
          -  Non-ambulatory or refuse to practice exercise program&#xD;
&#xD;
          -  Visual or vestibular system impairment&#xD;
&#xD;
          -  Patients with central nervous system involvement or metastasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marmara University Pendik Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.</citation>
    <PMID>28963591</PMID>
  </reference>
  <reference>
    <citation>Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grussinger V, Gollhofer A, Bertz H. Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy. Ann Oncol. 2014 Feb;25(2):493-9. doi: 10.1093/annonc/mdt568.</citation>
    <PMID>24478323</PMID>
  </reference>
  <reference>
    <citation>Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.</citation>
    <PMID>25261162</PMID>
  </reference>
  <reference>
    <citation>Cammisuli S, Cavazzi E, Baldissarro E, Leandri M. Rehabilitation of balance disturbances due to chemotherapy-induced peripheral neuropathy: a pilot study. Eur J Phys Rehabil Med. 2016 Aug;52(4):479-88. Epub 2016 May 31.</citation>
    <PMID>27243828</PMID>
  </reference>
  <reference>
    <citation>Nurgalieva Z, Xia R, Liu CC, Burau K, Hardy D, Du XL. Risk of chemotherapy-induced peripheral neuropathy in large population-based cohorts of elderly patients with breast, ovarian, and lung cancer. Am J Ther. 2010 Mar-Apr;17(2):148-58. doi: 10.1097/MJT.0b013e3181a3e50b.</citation>
    <PMID>19417586</PMID>
  </reference>
  <reference>
    <citation>Hershman DL, Lacchetti C, Loprinzi CL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline Summary. J Oncol Pract. 2014 Nov;10(6):e421-e424. doi: 10.1200/JOP.2014.001776. No abstract available.</citation>
    <PMID>29424607</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hitit University</investigator_affiliation>
    <investigator_full_name>Yeliz Bahar Ozdemir</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>peripheral neuropathy</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03798379
org study id: 09.2015.278
nct id: NCT03798379
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the effect of lower extremity strengthening and balance exercises on balance,
      quality of life and neuropathic pain of the cancer patients receiving neurotoxic
      chemotherapy.
Cancer-related mortality rates decreased considerably thanks to novel treatment methods and
      new agents over the last two decades. Although chemotherapy (CT) is an effective treatment
      type in reducing the size of the tumor and eliminating metastases, it may harm many different
      organs and systems due to short & long-term side effects. Peripheral neuropathy (PN) is
      regarded as a neurological and clinical side effect for cancer patients. PN may arise as a
      paraneoplastic symptom but more commonly occurs with neurotoxic CT agents. Short & long-term
      side effects that may damage sensory, motor, and autonomic neurons. This damage to the
      small-fiber sensory nerves causes a change in the sense of touch, pain, and warmth, while the
      damage to the large-fiber nerves causes a change in the sense of vibration and
      proprioception. Motor nerve damage affects voluntary movement, muscle tone, and coordination,
      and damage to the autonomic nervous system affects intestinal motility and blood pressure
      over smooth muscles. Despite the fact that studies on PN treatment have generally focused on
      pharmacological agents reducing pain or treating selected side effects, no agent that may be
      preventive for chemotherapy induced Peripheral Neuropathy (CIPN) due to neurotoxic
      chemotherapy has been recommended in the review of the American Society of Clinical Oncology.

      Side effects due to CT such as anorexia, nausea, vomiting, mucositis, diarrhea, anemia or PN
      may lead to impairment in the quality of life of the patient and may significantly reduce the
      level of physical activity. Neurotoxic and ototoxic effects may cause ataxia, paresthesia and
      dysesthesia, leading to gait, and balance disorders. CIPN has been associated with balance
      disorder, loss of function and reduced quality of life in the literature. It may result in
      loss of balance, difficulty in ambulation, increase in the frequency of collapse and
      accordingly increase in injuries. Despite the fact that medical treatments used in CIPN are
      often helpful in the treatment of neuropathic pain, no effect has been observed on muscle
      strength, gait, and balance. It is believed that muscle strength and balance exercises, such
      as aerobic exercises, can provide mitochondria with oxygen and glucose by increasing blood
      supply, thereby contributing to energy production and reducing symptoms. Current data suggest
      that exercise is applicable, safe, and beneficial for this group of patients. Balance
      exercises at an early stage may prevent or delay the onset of sensory and motor symptoms.
      Although exercise is accepted as a supportive treatment, which should be addressed more
      seriously for a patient population with PN, there is not enough information in the literature
      on timing, frequency, and mode of administration of the treatment program that will be
      carried out in this specific group of patients.

      The aim of this study is to investigate the effects of therapeutic exercise program including
      concurrently initiated strengthening, balance and aerobic exercises on the symptoms, balance
      status and quality of life of the group of patients who have a limited physical activity, a
      risk of developing PN following the treatment, and will have a long-term bed rest and compare
      with the group of patients not receiving any exercise program in the same treatment period.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Non randomized, single blind, prospective
measure: Balance assessment
time frame: 3 months
description: NeuroCom Balance Master® device (Natus Medical, San Carlos, California, USA) is a balance evaluation device measuring the position of the center of gravity, postural control along with static and dynamic stability.
measure: Berg balance scale
time frame: 3 months
description: Berg balance scale used in the evaluation of balance based on performance is a 14-item measure in which patient is required to perform different activities.14 different activities are scored between 0 (worst) and 4 (best) according to the patient's performance. The maximum score is 56. A total score close to 56 indicates that the balance of patient is good.
measure: PainDETECT: questionnaire
time frame: 3 months
description: The presence of neuropathic pain was evaluated with the painDETECT questionnaire. The maximum score is 35 and a high score indicates the severity of neuropathic pain. When the PD-Q score is more than 13, it is indicated the presence of neuropathic pain component.
measure: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
time frame: 3 months
description: It is a questionnaire developed by the European Organization for Research and Treatment of Cancer and used to assess the quality of life of cancer patients participating in clinical trials and includes a variety of components. Patients' higher points of functional scale and general health status scale and lower points of symptom scale scores indicate a high QoL.
arm group label: Exercise group
arm group type: Active Comparator
description: Eligible patients who were planned to receive neurotoxic chemotherapy
arm group label: Control group
arm group type: No Intervention
description: Patients eligible for the study and received the 3rd cycle of chemotherapy
intervention type: Other
intervention name: Exercise
description: Strengthening, balance and aerobic exercises were explained to the patients examined before chemotherapy sessions and demonstrated by applying on the patient.
arm group label: Exercise group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.
PMID: 28963591
citation: Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grussinger V, Gollhofer A, Bertz H. Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy. Ann Oncol. 2014 Feb;25(2):493-9. doi: 10.1093/annonc/mdt568.
PMID: 24478323
citation: Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
PMID: 25261162
citation: Cammisuli S, Cavazzi E, Baldissarro E, Leandri M. Rehabilitation of balance disturbances due to chemotherapy-induced peripheral neuropathy: a pilot study. Eur J Phys Rehabil Med. 2016 Aug;52(4):479-88. Epub 2016 May 31.
PMID: 27243828
citation: Nurgalieva Z, Xia R, Liu CC, Burau K, Hardy D, Du XL. Risk of chemotherapy-induced peripheral neuropathy in large population-based cohorts of elderly patients with breast, ovarian, and lung cancer. Am J Ther. 2010 Mar-Apr;17(2):148-58. doi: 10.1097/MJT.0b013e3181a3e50b.
PMID: 19417586
citation: Hershman DL, Lacchetti C, Loprinzi CL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline Summary. J Oncol Pract. 2014 Nov;10(6):e421-e424. doi: 10.1200/JOP.2014.001776. No abstract available.
PMID: 29424607
responsible party type: Principal Investigator
investigator affiliation: Hitit University
investigator full name: Yeliz Bahar Ozdemir
investigator title: Principal investigator
mesh term: Peripheral Nervous System Diseases
sharing ipd: Undecided