<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/NCT03232541</url>
  </required_header>
  <id_info>
    <org_study_id>Emesis 001</org_study_id>
    <nct_id>NCT03232541</nct_id>
  </id_info>
  <brief_title>The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting</brief_title>
  <official_title>The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting: a Randomized, Sham-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Västernorrland County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Västervik Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Falu Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Västernorrland County Council, Sweden</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Nausea and vomiting (emesis) is a common and burdensome side-effect of emetogenic&#xD;
      chemotherapy. Emesis affects both the patient's quality of life and induces high costs within&#xD;
      the health-care system. Many patients are interested in acupuncture, despite weak scrientific&#xD;
      evidence for its effects beside non-specific effects. Few credibly sham-controlled studies&#xD;
      have previously been conducted. The therapist's care and communication during acupuncture as&#xD;
      well as during standard care may induce non-specific effects, such as placebo effects,&#xD;
      potentially driven by the patient's expectations. It is not known if the type of&#xD;
      communication, in terms of how positive the therapist communicates regarding expected&#xD;
      effects, affects the effect of antiemetic treatments.&#xD;
&#xD;
      Aims: To investigate if chemotherapy-induced emesis, treatment expectancy and quality of life&#xD;
      differ between patients who receive A) standard care including antiemetics, B) standard care&#xD;
      plus sham acupuncture or C) standard treatment plus genuine acupuncture by a therapist who&#xD;
      emphasizes the positive expected outcomes of the treatment, compared to a therapist who&#xD;
      communicates neutral regarding the expected outcomes.&#xD;
&#xD;
      Procedure: The eligible patients will be randomized to A) standard care, including&#xD;
      antiemetics or to B) standard treatment plus sham acupuncture or C) standard treatment plus&#xD;
      genuine acupuncture. Within the three groups, the patients are randomized to receive either&#xD;
      neutral or positive communication with the therapist during the treatment.&#xD;
&#xD;
      Outcome measures: The primary outcome is intensity of nausea within the five days after the&#xD;
      chemotherapy session in patients receiving positive or neutral communication. Data collection&#xD;
      of nausea and vomiting, expectations, and quality of life is performed at baseline the day&#xD;
      before the studied chemotherapy session, during 10 days after the studied chemotherapy&#xD;
      session, and at a follow-up ten days after the last chemotherapy session.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Nausea and vomiting (emesis) is a common and burdensome side-effect of emetogenic&#xD;
      chemotherapy. Emesis affects both the patient's quality of life and induces high costs within&#xD;
      the health-care system. Many patients are interested in acupuncture, despite weak scrientific&#xD;
      evidence for its effects beside non-specific effects. Few credibly sham-controlled studies&#xD;
      have previously been conducted. The therapist's care and communication during acupuncture as&#xD;
      well as during standard care may induce non-specific effects, such as placebo effects,&#xD;
      potentially driven by the patient's expectations. It is not known if the type of&#xD;
      communication, in terms of how positive the therapist communicates regarding expected&#xD;
      effects, affects the effect of antiemetic treatments.&#xD;
&#xD;
      Aims: To investigate if chemotherapy-induced emesis, treatment expectancy and quality of life&#xD;
      differ between patients who receive A) standard care including antiemetics, B) standard care&#xD;
      plus sham acupuncture or C) standard treatment plus genuine acupuncture by a therapist who&#xD;
      emphasizes the positive expected outcomes of the treatment, compared to a therapist who&#xD;
      communicates neutral regarding the expected outcomes.&#xD;
&#xD;
      Procedure: Patients undergoing chemotherapy for cancer at three Swedish oncology departments&#xD;
      will receive written and oral study information and are screened for study criteria. The&#xD;
      eligible patients will be randomized to A) standard care, including antiemetics or to B)&#xD;
      standard treatment plus sham acupuncture or C) standard treatment plus genuine acupuncture.&#xD;
      Within the three groups, the patients are randomized to receive either neutral or positive&#xD;
      communication with the therapist during the treatment.&#xD;
&#xD;
      Outcome measures: The primary outcome is intensity of nausea within the five days after the&#xD;
      chemotherapy session in patients receiving positive or neutral communication. Data collection&#xD;
      of nausea and vomiting, expectations, and quality of life is performed at baseline the day&#xD;
      before the studied chemotherapy session, during 10 days after the studied chemotherapy&#xD;
      session, and at a follow-up ten days after the last chemotherapy session.&#xD;
&#xD;
      Qualitative interviews regarding the patients' experiences of the communication with the&#xD;
      professionals are conducted with a strategicaly selected group of patients from all&#xD;
      randomization combinations. The selection aims to provide heterogenicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 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>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>All other care providers beside the acupuncture/sham providing therapists are blinded to randomization group. For example, care providers providing the standard care antiemetic treatment and the chemotherapy per se are blinded for randomization group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days).</measure>
    <time_frame>In the morning of day 1-5 (the day of chemotherapy and the four following days).</time_frame>
    <description>Visual Analogue Scale (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The patient´s treatment expectations</measure>
    <time_frame>Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).</time_frame>
    <description>Visual analogue scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of well-being</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of well-being</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>Verbal category scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of well-being</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of well-being</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>FACT-G</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of activity</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of activity</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>Verbal category scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of activity</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of activity</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>FACT-G</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>Verbal category scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.</time_frame>
    <description>FACT-G</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost-analyzes.</measure>
    <time_frame>Emesis outcomes are measured every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).</time_frame>
    <description>Costs per patient, in relation to emesis outcomes and in relation to quality of life.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">288</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Bladder Cancer</condition>
  <condition>Testicular Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Chemotherapy-induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Standard care (A)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard care (A) with neutral communication (A1) or positive communication (A2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham acupuncture (B)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard nausea treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genuine acupuncture (C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard nausea treatment plus Genuine acupuncture (C) with neutral communication (C1) or positive communication (C2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>A) Ordinary nausea treatment means receiving ordinary antiemetic medications. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.</description>
    <arm_group_label>Standard care (A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham acupuncture</intervention_name>
    <description>B) Sham acupuncture is administered bilaterally to a non-acupuncture point two body-inches proximal and one body-inch radial from PC6 using the telescopic Park Sham Device. The sham-needle is blunt and glides upward into its handle instead of penetrating. Marking tubes hold the needle in place. The therapist gives an illusion of manipulating the needle by turning it three times until it touches the skin, but no specific needle sensation (&quot;deqi&quot;) will occur. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.</description>
    <arm_group_label>Sham acupuncture (B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Genuine acupuncture</intervention_name>
    <description>C) Acupuncture will be administered bilaterally to the standard antiemetic point PC6 located two body-inches proximal of the wrist crease, between the tendons of palmaris longus and flexor carpi radialis. Sharp acupuncture needles will be inserted into a depth of a half body-inch. The needles will be manipulated three times (at the start, middle and end of the treatment session) by twirling and lifting until deqi occurres. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.</description>
    <arm_group_label>Genuine acupuncture (C)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of at least 18 years of age&#xD;
&#xD;
          -  Breast, colorectal, bladder, testicular or prostate cancer&#xD;
&#xD;
          -  Receiving adjuvant or neo-adjuvant intravenous chemotherapy inducing medium or high&#xD;
             risk for emesis&#xD;
&#xD;
          -  Willing and capable to give their informed consent and to take part of the treatment&#xD;
             and data collection procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Consumption of antiemetics or experiences of persistent nausea, which will persist&#xD;
             within 24 hours prior to the start of the chemotherapy session&#xD;
&#xD;
          -  Hemophilia&#xD;
&#xD;
          -  Former participation in the same study&#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>Anna E Enblom, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ylva Widgren, MSP</last_name>
    <phone>+46 70 089 68 71</phone>
    <email>ylva.widgren@liu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anna E Enblom, PhD</last_name>
    <phone>+46 70 089 51 49</phone>
    <email>anna.enblom@liu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sundsvall Hospital</name>
      <address>
        <city>Sundsvall</city>
        <zip>SE-85186</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ylva Widgren</last_name>
      <email>ylva.widgren@liu.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Västernorrland County Council, Sweden</investigator_affiliation>
    <investigator_full_name>Ylva Widgren</investigator_full_name>
    <investigator_title>Study coordinator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Testicular Neoplasms</mesh_term>
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</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/NCT03232541
org study id: Emesis 001
nct id: NCT03232541
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Background: Nausea and vomiting (emesis) is a common and burdensome side-effect of emetogenic
      chemotherapy. Emesis affects both the patient's quality of life and induces high costs within
      the health-care system. Many patients are interested in acupuncture, despite weak scrientific
      evidence for its effects beside non-specific effects. Few credibly sham-controlled studies
      have previously been conducted. The therapist's care and communication during acupuncture as
      well as during standard care may induce non-specific effects, such as placebo effects,
      potentially driven by the patient's expectations. It is not known if the type of
      communication, in terms of how positive the therapist communicates regarding expected
      effects, affects the effect of antiemetic treatments.

      Aims: To investigate if chemotherapy-induced emesis, treatment expectancy and quality of life
      differ between patients who receive A) standard care including antiemetics, B) standard care
      plus sham acupuncture or C) standard treatment plus genuine acupuncture by a therapist who
      emphasizes the positive expected outcomes of the treatment, compared to a therapist who
      communicates neutral regarding the expected outcomes.

      Procedure: The eligible patients will be randomized to A) standard care, including
      antiemetics or to B) standard treatment plus sham acupuncture or C) standard treatment plus
      genuine acupuncture. Within the three groups, the patients are randomized to receive either
      neutral or positive communication with the therapist during the treatment.

      Outcome measures: The primary outcome is intensity of nausea within the five days after the
      chemotherapy session in patients receiving positive or neutral communication. Data collection
      of nausea and vomiting, expectations, and quality of life is performed at baseline the day
      before the studied chemotherapy session, during 10 days after the studied chemotherapy
      session, and at a follow-up ten days after the last chemotherapy session.
Background: Nausea and vomiting (emesis) is a common and burdensome side-effect of emetogenic
      chemotherapy. Emesis affects both the patient's quality of life and induces high costs within
      the health-care system. Many patients are interested in acupuncture, despite weak scrientific
      evidence for its effects beside non-specific effects. Few credibly sham-controlled studies
      have previously been conducted. The therapist's care and communication during acupuncture as
      well as during standard care may induce non-specific effects, such as placebo effects,
      potentially driven by the patient's expectations. It is not known if the type of
      communication, in terms of how positive the therapist communicates regarding expected
      effects, affects the effect of antiemetic treatments.

      Aims: To investigate if chemotherapy-induced emesis, treatment expectancy and quality of life
      differ between patients who receive A) standard care including antiemetics, B) standard care
      plus sham acupuncture or C) standard treatment plus genuine acupuncture by a therapist who
      emphasizes the positive expected outcomes of the treatment, compared to a therapist who
      communicates neutral regarding the expected outcomes.

      Procedure: Patients undergoing chemotherapy for cancer at three Swedish oncology departments
      will receive written and oral study information and are screened for study criteria. The
      eligible patients will be randomized to A) standard care, including antiemetics or to B)
      standard treatment plus sham acupuncture or C) standard treatment plus genuine acupuncture.
      Within the three groups, the patients are randomized to receive either neutral or positive
      communication with the therapist during the treatment.

      Outcome measures: The primary outcome is intensity of nausea within the five days after the
      chemotherapy session in patients receiving positive or neutral communication. Data collection
      of nausea and vomiting, expectations, and quality of life is performed at baseline the day
      before the studied chemotherapy session, during 10 days after the studied chemotherapy
      session, and at a follow-up ten days after the last chemotherapy session.

      Qualitative interviews regarding the patients' experiences of the communication with the
      professionals are conducted with a strategicaly selected group of patients from all
      randomization combinations. The selection aims to provide heterogenicity.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: All other care providers beside the acupuncture/sham providing therapists are blinded to randomization group. For example, care providers providing the standard care antiemetic treatment and the chemotherapy per se are blinded for randomization group.
measure: Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days).
time frame: In the morning of day 1-5 (the day of chemotherapy and the four following days).
description: Visual Analogue Scale (VAS).
measure: The patient´s treatment expectations
time frame: Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).
description: Visual analogue scale (VAS)
measure: Level of well-being
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: VAS
measure: Level of well-being
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: Verbal category scales
measure: Level of well-being
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: EQ-5D
measure: Level of well-being
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: FACT-G
measure: Level of activity
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: VAS
measure: Level of activity
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: Verbal category scales
measure: Level of activity
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: EQ-5D
measure: Level of activity
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: FACT-G
measure: Quality of life
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: VAS
measure: Quality of life
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: Verbal category scales
measure: Quality of life
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: EQ-5D
measure: Quality of life
time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
description: FACT-G
measure: Cost-analyzes.
time frame: Emesis outcomes are measured every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).
description: Costs per patient, in relation to emesis outcomes and in relation to quality of life.
arm group label: Standard care (A)
arm group type: Other
description: Standard care (A) with neutral communication (A1) or positive communication (A2)
arm group label: Sham acupuncture (B)
arm group type: Placebo Comparator
description: Standard nausea treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2)
arm group label: Genuine acupuncture (C)
arm group type: Experimental
description: Standard nausea treatment plus Genuine acupuncture (C) with neutral communication (C1) or positive communication (C2)
intervention type: Other
intervention name: Standard care
description: A) Ordinary nausea treatment means receiving ordinary antiemetic medications. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.
arm group label: Standard care (A)
intervention type: Device
intervention name: Sham acupuncture
description: B) Sham acupuncture is administered bilaterally to a non-acupuncture point two body-inches proximal and one body-inch radial from PC6 using the telescopic Park Sham Device. The sham-needle is blunt and glides upward into its handle instead of penetrating. Marking tubes hold the needle in place. The therapist gives an illusion of manipulating the needle by turning it three times until it touches the skin, but no specific needle sensation ("deqi") will occur. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.
arm group label: Sham acupuncture (B)
intervention type: Device
intervention name: Genuine acupuncture
description: C) Acupuncture will be administered bilaterally to the standard antiemetic point PC6 located two body-inches proximal of the wrist crease, between the tendons of palmaris longus and flexor carpi radialis. Sharp acupuncture needles will be inserted into a depth of a half body-inch. The needles will be manipulated three times (at the start, middle and end of the treatment session) by twirling and lifting until deqi occurres. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.
arm group label: Genuine acupuncture (C)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna E Enblom, PhD
role: Principal Investigator
affiliation: Linkoeping University
last name: Ylva Widgren, MSP
phone: +46 70 089 68 71
email: ylva.widgren@liu.se
last name: Anna E Enblom, PhD
phone: +46 70 089 51 49
email: anna.enblom@liu.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Västernorrland County Council, Sweden
investigator full name: Ylva Widgren
investigator title: Study coordinator
mesh term: Testicular Neoplasms
mesh term: Nausea
mesh term: Vomiting