<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/NCT03783546</url>
  </required_header>
  <id_info>
    <org_study_id>18-371</org_study_id>
    <nct_id>NCT03783546</nct_id>
  </id_info>
  <brief_title>Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial</brief_title>
  <official_title>Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Comprehensive and Integrative Medicine Institute of South Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is evaluating acupuncture, a medical therapy in which hair-thin,&#xD;
      stainless steel needles are shallowly inserted into specific points to help the body's&#xD;
      natural healing process, as a possible treatment to reduce hot flashes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hot flashes are a sensation of sudden onset of body warmth, flushing and sweating. Hot&#xD;
      flashes are common side effects of breast cancer treatments and can affect mood and daily&#xD;
      life. Medications can help ease hot flashes, but many patients continue to experience&#xD;
      symptoms despite these treatments.&#xD;
&#xD;
      Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are&#xD;
      inserted into various spots on the skin, with the goal of affecting body's natural healing&#xD;
      system. Acupuncture has been tested in clinical trials in cancer patients and has been shown&#xD;
      to be helpful in treating a number of side effects of cancer treatment, such as nausea and&#xD;
      vomiting from chemotherapy. A few early studies have suggested that acupuncture may help to&#xD;
      lessen hot flashes, but more information is needed about the benefits of acupuncture in&#xD;
      breast cancer patients.&#xD;
&#xD;
      This study is being done to test whether acupuncture can help to reduce the number and&#xD;
      intensity of hot flashes in breast cancer patients who are being treated with mediations such&#xD;
      as tamoxifen and aromatase inhibitors, such as anastrozole (Arimidex), exemestane (Aromasin),&#xD;
      and letrozole (Femara).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in mean weekly HFS score between acupuncture and usual care arms at the end of week 10</measure>
    <time_frame>10 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the total and subscores in Functional Assessment of Cancer Therapy- Breast Cancer</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the total and subscores in Functional Assessment of Cancer Therapy- Endocrine Subscale</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma proinflammatory cytokines</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Immediate Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive a standardized acupuncture protocol for a 10-week period&#xD;
20 sessions: twice a week for 10 weeks&#xD;
After the completion of the 10 weeks main study period, participants will cross over to the usual care as a follow-up without acupuncture for additional 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive standard usual care without acupuncture for 10 weeks&#xD;
Participants will cross over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system</description>
    <arm_group_label>Immediate Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>the current standard of care with non-hormonal pharmacotherapy of western medicine</description>
    <arm_group_label>Delayed acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of histologically or cytologically proven Stage I-III breast cancer with&#xD;
             estrogen receptor positive with HER-2 positive or negative tumor;&#xD;
&#xD;
          -  Premenopausal or postmenopausal status;&#xD;
&#xD;
          -  Completed all primary chemotherapy and surgery;&#xD;
&#xD;
          -  Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase&#xD;
             inhibitors) with or without ovarian function suppression for at least 4 weeks at study&#xD;
             entry; the use of Trastuzumab after adjuvant chemotherapy is allowed;&#xD;
&#xD;
          -  Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot&#xD;
             flashes per week (2 hot flashes per day) during the week prior to the study entry;&#xD;
&#xD;
          -  Age ≥ 18 years;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of&#xD;
        hormonal therapy during the study period;&#xD;
&#xD;
          -  Unstable cardiac disease or myocardial infarction within 6 months prior to study&#xD;
             entry;&#xD;
&#xD;
          -  Uncontrolled seizure disorder or history of seizure;&#xD;
&#xD;
          -  Active clinically significant uncontrolled infection;&#xD;
&#xD;
          -  Use of acupuncture for hot flashes within 6 months prior to the study entry;&#xD;
&#xD;
          -  Uncontrolled major psychiatric disorders, such as major depression or psychosis;&#xD;
&#xD;
          -  Newly starting pharmacologic treatment of hot flashes such as selective serotonin&#xD;
             reuptake inhibitors (SSRIs) and/or anti-convulsant for less than 4 weeks prior to&#xD;
             study entry. Participants may continue with medications or therapies for the treatment&#xD;
             of hot-flashes while participating in the study if the medication has been taking for&#xD;
             more than 4 weeks prior to study entry AND the dose of the medication is going to be&#xD;
             kept consistently during the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weidong Lu, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Weidong Lu, MB, MPH, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Hot Flashes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication.</ipd_time_frame>
    <ipd_access_criteria>Requests may be directed to: [contact information for Sponsor- Investigator or designee].</ipd_access_criteria>
  </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/NCT03783546
org study id: 18-371
nct id: NCT03783546
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This research study is evaluating acupuncture, a medical therapy in which hair-thin,
      stainless steel needles are shallowly inserted into specific points to help the body's
      natural healing process, as a possible treatment to reduce hot flashes.
Hot flashes are a sensation of sudden onset of body warmth, flushing and sweating. Hot
      flashes are common side effects of breast cancer treatments and can affect mood and daily
      life. Medications can help ease hot flashes, but many patients continue to experience
      symptoms despite these treatments.

      Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are
      inserted into various spots on the skin, with the goal of affecting body's natural healing
      system. Acupuncture has been tested in clinical trials in cancer patients and has been shown
      to be helpful in treating a number of side effects of cancer treatment, such as nausea and
      vomiting from chemotherapy. A few early studies have suggested that acupuncture may help to
      lessen hot flashes, but more information is needed about the benefits of acupuncture in
      breast cancer patients.

      This study is being done to test whether acupuncture can help to reduce the number and
      intensity of hot flashes in breast cancer patients who are being treated with mediations such
      as tamoxifen and aromatase inhibitors, such as anastrozole (Arimidex), exemestane (Aromasin),
      and letrozole (Femara).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline in mean weekly HFS score between acupuncture and usual care arms at the end of week 10
time frame: 10 weeks
measure: Response Rate
time frame: 10 weeks
measure: Changes in the total and subscores in Functional Assessment of Cancer Therapy- Breast Cancer
time frame: 2 years
measure: Changes in the total and subscores in Functional Assessment of Cancer Therapy- Endocrine Subscale
time frame: 2 years
measure: Pittsburgh Sleep Quality Index
time frame: 2 years
measure: Changes in plasma proinflammatory cytokines
time frame: 2 years
arm group label: Immediate Acupuncture
arm group type: Experimental
description: Will receive a standardized acupuncture protocol for a 10-week period
20 sessions: twice a week for 10 weeks
After the completion of the 10 weeks main study period, participants will cross over to the usual care as a follow-up without acupuncture for additional 10 weeks.
arm group label: Delayed acupuncture
arm group type: Active Comparator
description: Will receive standard usual care without acupuncture for 10 weeks
Participants will cross over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
intervention type: Device
intervention name: Acupuncture
description: Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system
arm group label: Immediate Acupuncture
intervention type: Other
intervention name: Usual Care
description: the current standard of care with non-hormonal pharmacotherapy of western medicine
arm group label: Delayed acupuncture
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Weidong Lu, PhD, MPH
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Weidong Lu, MB, MPH, PhD
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Hot Flashes
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor- Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd time frame: Data can be shared no earlier than 1 year following the date of publication.
ipd access criteria: Requests may be directed to: [contact information for Sponsor- Investigator or designee].