<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/NCT03762694</url>
  </required_header>
  <id_info>
    <org_study_id>UW 18-526</org_study_id>
    <nct_id>NCT03762694</nct_id>
  </id_info>
  <brief_title>The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy</brief_title>
  <official_title>The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy: A Randomized, Wait-list Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      This pilot study is designed to determine whether acupuncture is a feasible, effective and&#xD;
      safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as&#xD;
      compared with a wait-list control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in&#xD;
      breast cancer patients undergoing chemotherapy as compared with a wait-list control.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To determine whether the insomnia condition in the acupuncture group is significantly&#xD;
      improved when compared to the wait-list control group.&#xD;
&#xD;
      Design and strategy:&#xD;
&#xD;
      This is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be&#xD;
      recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list&#xD;
      control. All patients in the 2 groups will receive routine Western medical care for symptom&#xD;
      management.&#xD;
&#xD;
      Study instrument:&#xD;
&#xD;
      Insomnia Severity Index (ISI) will be employed as a primary outcome assessment.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      In the treatment group, 12 sessions acupuncture treatment (electroacupuncture &amp; auricular&#xD;
      acupressure) will be given twice a week for 6 weeks after randomization. In the wait-list&#xD;
      control group, no treatment except routine care will be given at the first 6 weeks, followed&#xD;
      by 12 sessions treatment as treatment group.&#xD;
&#xD;
      Main outcome measures:&#xD;
&#xD;
      Primary outcome: ISI scores will be measured at week 0, 3, 6, 10, 14.&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
      Pittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer&#xD;
      Therapy-Breast Cancer, and adverse events will be documented and compared between groups.&#xD;
&#xD;
      Data analysis: The primary endpoint will be the continuous ISI score. For the primary&#xD;
      analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test&#xD;
      on the average ISI score will be performed to access the significance of the treatment&#xD;
      effects; otherwise, a nonparametric approach will be taken.&#xD;
&#xD;
      Expected outcome: ISI score of the acupuncture group is expected to be significantly lower&#xD;
      than wait-list control group after 6 weeks of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 9, 2020</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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Insomnia Severity Index (ISI)</measure>
    <time_frame>week 0, 3, 6 (primary outcome), 10, 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>week 0, 3, 6, 10, 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep diary</measure>
    <time_frame>week 0, 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>week 0, 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy-Breast Cancer</measure>
    <time_frame>week 0, 6, 10, 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>week 0 to week 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Insomnia, Secondary</condition>
  <condition>Breast Cancer Female</condition>
  <condition>Chemotherapy</condition>
  <arm_group>
    <arm_group_label>Electroacupuncture (EA) and Auricular Acupuncture (AA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Electroacupuncture (EA) and Auricular Acupuncture (AA)</description>
    <arm_group_label>Electroacupuncture (EA) and Auricular Acupuncture (AA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female patients between 18 and 75 years of age;&#xD;
&#xD;
          2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;&#xD;
&#xD;
          3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6&#xD;
             months;&#xD;
&#xD;
          4. Insomnia onset after the diagnosis of breast cancer;&#xD;
&#xD;
          5. Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with&#xD;
             fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition&#xD;
             (DSM-5) diagnostic criteria for brief insomnia disorder;&#xD;
&#xD;
          6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;&#xD;
&#xD;
          7. Expected survival time of more than 6 months;&#xD;
&#xD;
          8. Ability to understand the nature of the study and willingness to give informed&#xD;
             consent;&#xD;
&#xD;
          9. Ability to provide responses during outcome measurement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Insomnia before the diagnosis of breast cancer;&#xD;
&#xD;
          2. Other sleep disorder (e.g., obstructive sleep apnoea);&#xD;
&#xD;
          3. Shift work or irregular sleep pattern;&#xD;
&#xD;
          4. Severe visual, hearing or language defects;&#xD;
&#xD;
          5. Severe hematological dysfunction (platelet count &lt;60,000/μL, haemoglobin &lt;8 g/dL or&#xD;
             absolute neutrophil count &lt;1000/μL);&#xD;
&#xD;
          6. With pacemakers or other electronic implants that could interfere with&#xD;
             electroacupuncture;&#xD;
&#xD;
          7. History of acupuncture use in the previous 3 months;&#xD;
&#xD;
          8. Participation in other clinical trials with intervention within 3 months of the&#xD;
             beginning of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 24, 2022</last_update_submitted>
  <last_update_submitted_qc>April 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Professor LAO Lixing</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT03762694
org study id: UW 18-526
nct id: NCT03762694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study is designed to determine whether acupuncture is a feasible, effective and
      safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as
      compared with a wait-list control.
Hypothesis:

      Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in
      breast cancer patients undergoing chemotherapy as compared with a wait-list control.

      Objective:

      To determine whether the insomnia condition in the acupuncture group is significantly
      improved when compared to the wait-list control group.

      Design and strategy:

      This is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be
      recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list
      control. All patients in the 2 groups will receive routine Western medical care for symptom
      management.

      Study instrument:

      Insomnia Severity Index (ISI) will be employed as a primary outcome assessment.

      Intervention:

      In the treatment group, 12 sessions acupuncture treatment (electroacupuncture & auricular
      acupressure) will be given twice a week for 6 weeks after randomization. In the wait-list
      control group, no treatment except routine care will be given at the first 6 weeks, followed
      by 12 sessions treatment as treatment group.

      Main outcome measures:

      Primary outcome: ISI scores will be measured at week 0, 3, 6, 10, 14.

      Secondary outcomes:

      Pittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer
      Therapy-Breast Cancer, and adverse events will be documented and compared between groups.

      Data analysis: The primary endpoint will be the continuous ISI score. For the primary
      analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test
      on the average ISI score will be performed to access the significance of the treatment
      effects; otherwise, a nonparametric approach will be taken.

      Expected outcome: ISI score of the acupuncture group is expected to be significantly lower
      than wait-list control group after 6 weeks of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Insomnia Severity Index (ISI)
time frame: week 0, 3, 6 (primary outcome), 10, 14
measure: Pittsburgh Sleep Quality Index
time frame: week 0, 3, 6, 10, 14
measure: Sleep diary
time frame: week 0, 6
measure: Actigraphy
time frame: week 0, 6
measure: Functional Assessment of Cancer Therapy-Breast Cancer
time frame: week 0, 6, 10, 14
measure: Adverse events
time frame: week 0 to week 6
arm group label: Electroacupuncture (EA) and Auricular Acupuncture (AA)
arm group type: Experimental
description: 12 sessions acupuncture treatment (EA+AA) will be given twice a week for 6 weeks after randomization.
arm group label: Wait-list control
arm group type: No Intervention
description: No treatment except routine care will be given at the first 6 weeks, followed by 12 sessions treatment as Acupuncture group.
intervention type: Device
intervention name: Acupuncture
description: Electroacupuncture (EA) and Auricular Acupuncture (AA)
arm group label: Electroacupuncture (EA) and Auricular Acupuncture (AA)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Professor LAO Lixing
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Sleep Initiation and Maintenance Disorders