<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/NCT04446819</url>
  </required_header>
  <id_info>
    <org_study_id>BUAY-20-01</org_study_id>
    <nct_id>NCT04446819</nct_id>
  </id_info>
  <brief_title>Compression Gloves to Reduce Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity (REMAINING)</brief_title>
  <acronym>REMAINING</acronym>
  <official_title>A Multicenter Prospective Phase III Clinical Study of Reducing Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity of Upper Extremities With Compression Gloves (REMAINING)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan 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>
      Nanoparticle albumin-bound paclitaxel has greater efficacy and favorable safety profile than&#xD;
      standard paclitaxel. However, rate of neuropathy caused by nanoparticle albumin-bound&#xD;
      paclitaxel is higher than standard paclitaxel, and is one of its dose-limited toxicities.&#xD;
      Previously, compression therapy by surgical gloves has shown effectiveness in preventing&#xD;
      chemotherapy-induced neuropathy. We designed this multi-center prospective self-control phase&#xD;
      III study to investigate the efficacy of compression gloves to reduce albumin-binding&#xD;
      paclitaxel induced sensory and motor neurotoxicity of upper extremities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 12, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in severe peripheral sensory neurotoxicity rates</measure>
    <time_frame>3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).</time_frame>
    <description>Differences in peripheral sensory neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in total peripheral sensory neurotoxicity rates</measure>
    <time_frame>3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).</time_frame>
    <description>Differences in total peripheral sensory neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in severe peripheral motor neurotoxicity rates</measure>
    <time_frame>3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).</time_frame>
    <description>Differences in severe peripheral motor neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in total peripheral motor neurotoxicity rates</measure>
    <time_frame>3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).</time_frame>
    <description>Differences in total peripheral motor neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in peripheral neurotoxicity questionaire scores</measure>
    <time_frame>3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).</time_frame>
    <description>Differences in peripheral neurotoxicity questionaire scores between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity.</measure>
    <time_frame>From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days).</time_frame>
    <description>Adverse events related to compression gloves intervention are collected.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients diagnosed with solid tumors who are about to received albumin-binding paclitaxel monotherapy are recruited. Dominant hands and non-dominant hands are treated with small-size compression gloves and suitable-size compression gloves, respectively, during the administration of albumin-binding paclitaxel.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Compression gloves</intervention_name>
    <description>Patients wear small-size compression gloves (one or two size smaller than suitable size) for dominant hands and suitable-size compression gloves for non-dominant hands for 90 minutes during the administration of albumin-binding paclitaxel (start from 30 minutes before albumin-binding paclitaxel infusion).</description>
    <arm_group_label>Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are diagnosed with pathologically confirmed solid tumors.&#xD;
&#xD;
          -  Patients are about to receive albumin-binding paclitaxel monotherapy (at least 4&#xD;
             cycles anticipated) by physicians' choice.&#xD;
&#xD;
          -  Patients should have baseline Grade 0 peripheral sensory and motor neurotoxicity&#xD;
             (NCI-CTCAE 5.0).&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status ≤ 1.&#xD;
&#xD;
          -  Biochemical tests within 7 days before inclusion should meet the following criteria:&#xD;
&#xD;
               -  Hemoglobin ≥ 90g/L, white blood cell count ≥ 3500/mm^3, neutrophil ≥ 1500/mm^3&#xD;
                  and platelet ≥ 75000/mm^3 with no blood transfusion or hematopoietic&#xD;
                  colony-stimulating factors in the past 14 days.&#xD;
&#xD;
               -  Creatinine ≤ 1.5 times upper limit of normal (ULN).&#xD;
&#xD;
               -  Liver function: For patients without liver metastasis, alanine aminotransferase&#xD;
                  (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 1.5&#xD;
                  times ULN, and total bilirubin ≤ 1.25 times ULN. For patients with liver&#xD;
                  metastasis, ALT, AST and ALP ≤ 5 times ULN and total bilirubin ≤ 1.5 times ULN.&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks.&#xD;
&#xD;
          -  No history of severe diseases in important organs including heart, lung, liver, and&#xD;
             kidney.&#xD;
&#xD;
          -  Willingness to sign a written informed consent.&#xD;
&#xD;
          -  Willingness to adhere to dose and visit schedules.&#xD;
&#xD;
          -  Women of child-bearing ages should be willing to take birth control methods during&#xD;
             treatment and within 8 weeks after trial, and pregnancy test (blood or urine) within&#xD;
             14 days before inclusion should be negative (if positive, ultrasound should be&#xD;
             performed to rule out pregnancy). Male patients should be willing to take birth&#xD;
             control methods during treatment and within 8 weeks after trial or be sterilized by&#xD;
             surgery .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncontrolled and severe infection.&#xD;
&#xD;
          -  Patients with meningeal metastasis, symptomatic brain metastasis, spinal cord&#xD;
             compression, or new discovery of brain or pia mater diseases during screening.&#xD;
             Patients who finish brain local control treatment, manifest stable symptoms and&#xD;
             without brain hemorrhage in radiological screening can be included in the trial.&#xD;
&#xD;
          -  Investigators decide the patient unsuitable for the trial.&#xD;
&#xD;
        Elimination Criteria:&#xD;
&#xD;
          -  Patients have allergy to albumin-binding paclitaxel and are unable to finish 4 cycles&#xD;
             of treatment.&#xD;
&#xD;
          -  Patients are unable to finish 4 cycles of albumin-binding paclitaxel monotherapy due&#xD;
             to intolerable toxicities even after twice dose reduction. If due to toxicity of&#xD;
             peripheral neurotoxicity, evaluations should be performed and recorded for further&#xD;
             case study.&#xD;
&#xD;
          -  Patients are unable to finish 4 cycles of albumin-binding paclitaxel monotherapy&#xD;
             because of change of regimen due to progression or death.&#xD;
&#xD;
          -  Patients require to quit.&#xD;
&#xD;
          -  Patients are found to have situations that are not suitable for the trial after&#xD;
             inclusion.&#xD;
&#xD;
          -  Patients' hands are unfit for the compression gloves used in the trial (too big or too&#xD;
             small).&#xD;
&#xD;
          -  Any situations that investigators believe necessary for patients to quit the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jian Zhang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of medical oncology, Fudan University Shanghai Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jian Zhang, PhD</last_name>
    <phone>86-21-64175590</phone>
    <email>syner2000@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian Zhang, PhD</last_name>
      <phone>86-21-64175590</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Jian Zhang,MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Paclitaxel</keyword>
  <keyword>Compression gloves</keyword>
  <keyword>Compression therapy</keyword>
  <keyword>Neurotoxicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Neurotoxicity Syndromes</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/NCT04446819
org study id: BUAY-20-01
nct id: NCT04446819
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nanoparticle albumin-bound paclitaxel has greater efficacy and favorable safety profile than
      standard paclitaxel. However, rate of neuropathy caused by nanoparticle albumin-bound
      paclitaxel is higher than standard paclitaxel, and is one of its dose-limited toxicities.
      Previously, compression therapy by surgical gloves has shown effectiveness in preventing
      chemotherapy-induced neuropathy. We designed this multi-center prospective self-control phase
      III study to investigate the efficacy of compression gloves to reduce albumin-binding
      paclitaxel induced sensory and motor neurotoxicity of upper extremities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Differences in severe peripheral sensory neurotoxicity rates
time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
description: Differences in peripheral sensory neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
measure: Differences in total peripheral sensory neurotoxicity rates
time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
description: Differences in total peripheral sensory neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
measure: Differences in severe peripheral motor neurotoxicity rates
time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
description: Differences in severe peripheral motor neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
measure: Differences in total peripheral motor neurotoxicity rates
time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
description: Differences in total peripheral motor neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
measure: Differences in peripheral neurotoxicity questionaire scores
time frame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
description: Differences in peripheral neurotoxicity questionaire scores between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
measure: Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity.
time frame: From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days).
description: Adverse events related to compression gloves intervention are collected.
arm group label: Cohort
arm group type: Other
description: Patients diagnosed with solid tumors who are about to received albumin-binding paclitaxel monotherapy are recruited. Dominant hands and non-dominant hands are treated with small-size compression gloves and suitable-size compression gloves, respectively, during the administration of albumin-binding paclitaxel.
intervention type: Device
intervention name: Compression gloves
description: Patients wear small-size compression gloves (one or two size smaller than suitable size) for dominant hands and suitable-size compression gloves for non-dominant hands for 90 minutes during the administration of albumin-binding paclitaxel (start from 30 minutes before albumin-binding paclitaxel infusion).
arm group label: Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jian Zhang, PhD
role: Principal Investigator
affiliation: Department of medical oncology, Fudan University Shanghai Cancer Center
last name: Jian Zhang, PhD
phone: 86-21-64175590
email: syner2000@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Jian Zhang,MD
investigator title: Associate Professor
mesh term: Peripheral Nervous System Diseases
mesh term: Neurotoxicity Syndromes
sharing ipd: No