<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/NCT04461977</url>
  </required_header>
  <id_info>
    <org_study_id>26778919.3.0000.0072</org_study_id>
    <nct_id>NCT04461977</nct_id>
  </id_info>
  <brief_title>Acupuncture for Peripheral Neuropathy Induced by Paclitaxel in Early Stage Breast Cancer</brief_title>
  <official_title>Acupuncture for Treatment of Peripheral Neuropathy Induced by Neoadjuvant or Adjuvant Paclitaxel in Early Stage Breast Cancer: a Sham Controlled, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Brasileiro de Controle do Cancer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Brasileiro de Controle do Cancer</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study aims to evaluate the effectiveness of acupuncture in the treatment of&#xD;
      chemotherapy drug paclitaxel induced peripheral neuropathy in patients with early stage&#xD;
      breast cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with early stage breast cancer (stages I,II,III) who received paclitaxel in&#xD;
      neoadjuvant or adjuvant chemotherapy protocol and developed peripheral neuropathy will be&#xD;
      randomized to receive true acupuncture (intervention group) vs sham acupuncture (control),&#xD;
      once a week, for 8 weeks. The primary outcome is improvement of the symptoms by Neuropathic&#xD;
      Pain Symptom Inventory (NPSI) scale (Bouhassira,2004). The secondary outcomes are&#xD;
      improvements on Visual analog scale (VAS) and Quality of life by FACT-taxane (Cella, 2003)&#xD;
      questionnaire. These scales will be assessed in the Screening visit (baseline), week 4, week&#xD;
      6, week 8 and week 12. The study has duration of 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 30, 2020</start_date>
  <completion_date type="Anticipated">February 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 13, 2021</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>
    <intervention_model_description>True acupuncture vs sham acupuncture</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Sham acupuncture</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The change the effects of neuropathic pain syndromes management from baseline</measure>
    <time_frame>Screening visit (baseline), week 4, week 6, week 8, week 12</time_frame>
    <description>Neuropathic Pain Symptom Inventory (NPSI) scale. This tool included 12 items in total: 10 are differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain. The verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline pain intensity change</measure>
    <time_frame>Screening visit (baseline), week 4, week 6, week 8, week 12</time_frame>
    <description>Visual analog scale (VAS). The pain VAS is a unidimensional measure of pain intensity. It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 100 [100-mm scale]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in side effects associated with taxane treatments from baseline</measure>
    <time_frame>Screening visit (baseline), week 4, week 6, week 8, week 12</time_frame>
    <description>FACT-taxane questionnaire. It is a self-report instrument that was developed to measure the health-related Quality of life of patients receiving taxane-containing chemotherapy. This scale has 16 items, including an 11-item neurotoxicity subscale and five additional taxane-specific questions related to the effects of arthralgia, myalgia, and skin changes. The total score is calculated as the sum of the un-weighted subscale score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Peripheral Neuropathy Due to Chemotherapy</condition>
  <arm_group>
    <arm_group_label>A - true acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The selection of acupuncture points is based on Traditional Chinese Medicine (Wen 2011) and on previous studies (Jeong, 2018; Bao,2018), selected as main points: bilateral &quot;baxie&quot;, SJ5, &quot;bafeng&quot;, KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - sham acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain &quot;de qi&quot;, located near the real points in the hands and feet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>True acupuncture</intervention_name>
    <description>The selection of acupuncture points is based on Traditional Chinese Medicine (Wen, 2011) and on previous studies (Jeong,2018; Bao,2018), selected as main points: bilateral &quot;baxie&quot;, SJ5, &quot;bafeng&quot;, KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment. The needles will be inserted at a depth of 10 - 15 mm, being gently manipulated to obtain &quot;de qi&quot; sensation. The needles will be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.</description>
    <arm_group_label>A - true acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham acupuncture</intervention_name>
    <description>Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain &quot;de qi&quot;, located near the real points in the hands and feet. The needles will also be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.</description>
    <arm_group_label>B - sham acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years old.&#xD;
&#xD;
          -  Agreed to sign the Informed Consent Term&#xD;
&#xD;
          -  ECOG 0-1&#xD;
&#xD;
          -  Breast cancer stages I, II and III.&#xD;
&#xD;
          -  Received adjuvant or neoadjuvant chemotherapy containing weekly paclitaxel 80 mg/m2.&#xD;
&#xD;
          -  Peripheral sensory neuropathy grade 2 and 3 by the &quot;Common Terminology Criteria for&#xD;
             Adverse Events&quot; (CTCAE) v5.0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of peripheral neuropathy due to other comorbidities.&#xD;
&#xD;
          -  Prior treatment with chemotherapy for cancer other than breast cancer.&#xD;
&#xD;
          -  Use of medications to treat peripheral neuropathy.&#xD;
&#xD;
          -  Metastatic disease.&#xD;
&#xD;
          -  Presence of lymphedema of any degree.&#xD;
&#xD;
          -  History of coagulopathy or full anticoagulation.&#xD;
&#xD;
          -  Previous acupuncture treatment for any indication within the last 90 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin I Ter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Brasileiro de Controle do Cancer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lin I Ter, MD</last_name>
    <phone>+5511984736737</phone>
    <email>LINITER@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alayne Yamada, PhD</last_name>
    <email>alayne.pesquisa@ibcc-mooca.org.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto Brasileiro de Controle de Cancer (IBCC Oncologia)</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>03102-006</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alayne D Yamada, PhD</last_name>
      <phone>+55113473-4249</phone>
      <email>alayne.pesquisa@ibcc-mooca.org.br</email>
    </contact>
    <investigator>
      <last_name>Lin I Ter, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf</url>
    <description>Common Terminology Criteria for Adverse Events ( CTCAE ) version 5.0.</description>
  </link>
  <reference>
    <citation>Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.</citation>
    <PMID>15030944</PMID>
  </reference>
  <reference>
    <citation>Cella D, Peterman A, Hudgens S, Webster K, Socinski MA. Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane). Cancer. 2003 Aug 15;98(4):822-31. doi: 10.1002/cncr.11578.</citation>
    <PMID>12910528</PMID>
  </reference>
  <reference>
    <citation>Jeong YJ, Kwak MA, Seo JC, Park SH, Bong JG, Shin IH, Park SH. Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Trial. Evid Based Complement Alternat Med. 2018 Oct 21;2018:5367014. doi: 10.1155/2018/5367014. eCollection 2018.</citation>
    <PMID>30420895</PMID>
  </reference>
  <reference>
    <citation>Bao T, Seidman AD, Piulson L, Vertosick E, Chen X, Vickers AJ, Blinder VS, Zhi WI, Li Q, Vahdat LT, Dickler MN, Robson ME, Mao JJ. A phase IIA trial of acupuncture to reduce chemotherapy-induced peripheral neuropathy severity during neoadjuvant or adjuvant weekly paclitaxel chemotherapy in breast cancer patients. Eur J Cancer. 2018 Sep;101:12-19. doi: 10.1016/j.ejca.2018.06.008. Epub 2018 Jul 13.</citation>
    <PMID>30007894</PMID>
  </reference>
  <reference>
    <citation>de Andrade DC, Ferreira KA, Nishimura CM, Yeng LT, Batista AF, de Sa K, Araujo J, Stump PR, Kaziyama HH, Galhardoni R, Fonoff ET, Ballester G, Zakka T, Bouhassira D, Teixeira MJ. Psychometric validation of the Portuguese version of the Neuropathic Pain Symptoms Inventory. Health Qual Life Outcomes. 2011 Nov 30;9:107. doi: 10.1186/1477-7525-9-107.</citation>
    <PMID>22128801</PMID>
  </reference>
  <reference>
    <citation>Wen TS. Acupuntura Clássica Chinesa. Edição Dig. São Paulo: Cultrix; 2011.</citation>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peripheral Neuropathy</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Acupuncture</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>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/NCT04461977
org study id: 26778919.3.0000.0072
nct id: NCT04461977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The present study aims to evaluate the effectiveness of acupuncture in the treatment of
      chemotherapy drug paclitaxel induced peripheral neuropathy in patients with early stage
      breast cancer
Patients with early stage breast cancer (stages I,II,III) who received paclitaxel in
      neoadjuvant or adjuvant chemotherapy protocol and developed peripheral neuropathy will be
      randomized to receive true acupuncture (intervention group) vs sham acupuncture (control),
      once a week, for 8 weeks. The primary outcome is improvement of the symptoms by Neuropathic
      Pain Symptom Inventory (NPSI) scale (Bouhassira,2004). The secondary outcomes are
      improvements on Visual analog scale (VAS) and Quality of life by FACT-taxane (Cella, 2003)
      questionnaire. These scales will be assessed in the Screening visit (baseline), week 4, week
      6, week 8 and week 12. The study has duration of 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: True acupuncture vs sham acupuncture
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Sham acupuncture
measure: The change the effects of neuropathic pain syndromes management from baseline
time frame: Screening visit (baseline), week 4, week 6, week 8, week 12
description: Neuropathic Pain Symptom Inventory (NPSI) scale. This tool included 12 items in total: 10 are differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain. The verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of 10 descriptors.
measure: Baseline pain intensity change
time frame: Screening visit (baseline), week 4, week 6, week 8, week 12
description: Visual analog scale (VAS). The pain VAS is a unidimensional measure of pain intensity. It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
measure: Change in side effects associated with taxane treatments from baseline
time frame: Screening visit (baseline), week 4, week 6, week 8, week 12
description: FACT-taxane questionnaire. It is a self-report instrument that was developed to measure the health-related Quality of life of patients receiving taxane-containing chemotherapy. This scale has 16 items, including an 11-item neurotoxicity subscale and five additional taxane-specific questions related to the effects of arthralgia, myalgia, and skin changes. The total score is calculated as the sum of the un-weighted subscale score.
arm group label: A - true acupuncture
arm group type: Experimental
description: The selection of acupuncture points is based on Traditional Chinese Medicine (Wen 2011) and on previous studies (Jeong, 2018; Bao,2018), selected as main points: bilateral "baxie", SJ5, "bafeng", KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment.
arm group label: B - sham acupuncture
arm group type: Sham Comparator
description: Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain "de qi", located near the real points in the hands and feet.
intervention type: Other
intervention name: True acupuncture
description: The selection of acupuncture points is based on Traditional Chinese Medicine (Wen, 2011) and on previous studies (Jeong,2018; Bao,2018), selected as main points: bilateral "baxie", SJ5, "bafeng", KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment. The needles will be inserted at a depth of 10 - 15 mm, being gently manipulated to obtain "de qi" sensation. The needles will be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.
arm group label: A - true acupuncture
intervention type: Other
intervention name: Sham acupuncture
description: Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain "de qi", located near the real points in the hands and feet. The needles will also be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do.
arm group label: B - sham acupuncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lin I Ter, MD
role: Principal Investigator
affiliation: Instituto Brasileiro de Controle do Cancer
last name: Lin I Ter, MD
phone: +5511984736737
email: LINITER@gmail.com
last name: Alayne Yamada, PhD
email: alayne.pesquisa@ibcc-mooca.org.br
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
url: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf
description: Common Terminology Criteria for Adverse Events ( CTCAE ) version 5.0.
citation: Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
PMID: 15030944
citation: Cella D, Peterman A, Hudgens S, Webster K, Socinski MA. Measuring the side effects of taxane therapy in oncology: the functional assesment of cancer therapy-taxane (FACT-taxane). Cancer. 2003 Aug 15;98(4):822-31. doi: 10.1002/cncr.11578.
PMID: 12910528
citation: Jeong YJ, Kwak MA, Seo JC, Park SH, Bong JG, Shin IH, Park SH. Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Trial. Evid Based Complement Alternat Med. 2018 Oct 21;2018:5367014. doi: 10.1155/2018/5367014. eCollection 2018.
PMID: 30420895
citation: Bao T, Seidman AD, Piulson L, Vertosick E, Chen X, Vickers AJ, Blinder VS, Zhi WI, Li Q, Vahdat LT, Dickler MN, Robson ME, Mao JJ. A phase IIA trial of acupuncture to reduce chemotherapy-induced peripheral neuropathy severity during neoadjuvant or adjuvant weekly paclitaxel chemotherapy in breast cancer patients. Eur J Cancer. 2018 Sep;101:12-19. doi: 10.1016/j.ejca.2018.06.008. Epub 2018 Jul 13.
PMID: 30007894
citation: de Andrade DC, Ferreira KA, Nishimura CM, Yeng LT, Batista AF, de Sa K, Araujo J, Stump PR, Kaziyama HH, Galhardoni R, Fonoff ET, Ballester G, Zakka T, Bouhassira D, Teixeira MJ. Psychometric validation of the Portuguese version of the Neuropathic Pain Symptoms Inventory. Health Qual Life Outcomes. 2011 Nov 30;9:107. doi: 10.1186/1477-7525-9-107.
PMID: 22128801
citation: Wen TS. Acupuntura Clássica Chinesa. Edição Dig. São Paulo: Cultrix; 2011.
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
sharing ipd: No