<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/NCT04449315</url>
  </required_header>
  <id_info>
    <org_study_id>CentralDuPage</org_study_id>
    <nct_id>NCT04449315</nct_id>
  </id_info>
  <brief_title>Outpatient Oncology Aromatherapy for Symptom Management</brief_title>
  <official_title>Outpatient Oncology Aromatherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central DuPage Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central DuPage Hospital</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 purpose of this research study is to determine whether using aromatherapy during&#xD;
      chemotherapy infusion treatments in the outpatient Oncology setting promote relief of nausea&#xD;
      and anxiety.&#xD;
&#xD;
      The objectives of this study are: 1. To promote relief of nausea using peppermint&#xD;
      aromatherapy oil in an outpatient oncology setting. 2. To promote relief of anxiety using&#xD;
      lavender aromatherapy oil in an outpatient oncology setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subject Selection: Every outpatient oncology patient experiencing nausea and/or anxiety&#xD;
      during an infusion visit will be offered hospital-approved aromatherapy of Peppermint oil or&#xD;
      Lavender oil. If patient says yes, then they will be selected for the study and infusion&#xD;
      nurse will notify the study co-investigators or principal investigator. Informed consent will&#xD;
      then be obtained by co-investigators or principal investigator of the study. The consents as&#xD;
      well as the data collection tool sheets will be numbered without identifying patient's&#xD;
      personal information. Peppermint oil aromatherapy and/or lavender oil aromatherapy will then&#xD;
      be administered to consented patients.&#xD;
&#xD;
      Method of Subject Identification and Recruitment: Every outpatient oncology patient&#xD;
      experiencing nausea and/or anxiety during an infusion visit will be offered hospital-&#xD;
      approved aromatherapy of Peppermint oil or Lavender oil. If patient says yes, then they will&#xD;
      be selected for the study and infusion nurse will notify the study co-investigators or&#xD;
      principal investigator. Informed consent will then be obtained by co-investigators or&#xD;
      principal investigator of the study. The consents as well as the data collection tool sheets&#xD;
      will be numbered without identifying patient's personal information. Peppermint oil&#xD;
      aromatherapy and/or lavender oil aromatherapy will then be administered to consented&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post Intervention Interview From</measure>
    <time_frame>Immediately upon Completion of the patient's infusion</time_frame>
    <description>After the patients' infusion they will be asked questions from this form</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Anxiety</condition>
  <condition>Nausea</condition>
  <arm_group>
    <arm_group_label>Peppermint and Lavender Essential Oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Young Living Essential oil of Peppermint and Lavender will be used to patients who meet the inclusion criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Young Living Lavender Essential Oil</intervention_name>
    <description>For qualified patients one to two drops of hospital approved essential oil will be placed on a 4X4 gauze and will be offered to the patient during their infusion visit. This gauze will be placed in a sealable clear plastic bag and the patient will be instructed to use one sniff at a time.</description>
    <arm_group_label>Peppermint and Lavender Essential Oil</arm_group_label>
    <other_name>Young Living Peppermint Essential Oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All outpatient Oncology patients &gt; 18 years of age Non pregnant Not cognitively impaired&#xD;
        English speaking only Patients who report nausea and/or anxiety&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All outpatient oncology patients &lt;18 years of age Pregnant Cognitively impaired Non-English&#xD;
        Speaking Patients who do not report nausea and/or anxiety Patients with a known allergy to&#xD;
        peppermint and/or lavender aromatherapy oil&#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>Lorraine Mack, MSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central DuPage Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lorraine Mack, MSN</last_name>
    <phone>630-315-6025</phone>
    <email>lorraine.mack@nm.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Megha Shah, BSN</last_name>
    <email>megha.shah@nm.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Central DuPage</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60190</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Lorraine Mack, MSN</last_name>
      <phone>630-315-6025</phone>
      <email>lorraine.mack@nm.org</email>
    </contact>
    <investigator>
      <last_name>Lorraine Mack, MSN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</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/NCT04449315
org study id: CentralDuPage
nct id: NCT04449315
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this research study is to determine whether using aromatherapy during
      chemotherapy infusion treatments in the outpatient Oncology setting promote relief of nausea
      and anxiety.

      The objectives of this study are: 1. To promote relief of nausea using peppermint
      aromatherapy oil in an outpatient oncology setting. 2. To promote relief of anxiety using
      lavender aromatherapy oil in an outpatient oncology setting.
Subject Selection: Every outpatient oncology patient experiencing nausea and/or anxiety
      during an infusion visit will be offered hospital-approved aromatherapy of Peppermint oil or
      Lavender oil. If patient says yes, then they will be selected for the study and infusion
      nurse will notify the study co-investigators or principal investigator. Informed consent will
      then be obtained by co-investigators or principal investigator of the study. The consents as
      well as the data collection tool sheets will be numbered without identifying patient's
      personal information. Peppermint oil aromatherapy and/or lavender oil aromatherapy will then
      be administered to consented patients.

      Method of Subject Identification and Recruitment: Every outpatient oncology patient
      experiencing nausea and/or anxiety during an infusion visit will be offered hospital-
      approved aromatherapy of Peppermint oil or Lavender oil. If patient says yes, then they will
      be selected for the study and infusion nurse will notify the study co-investigators or
      principal investigator. Informed consent will then be obtained by co-investigators or
      principal investigator of the study. The consents as well as the data collection tool sheets
      will be numbered without identifying patient's personal information. Peppermint oil
      aromatherapy and/or lavender oil aromatherapy will then be administered to consented
      patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post Intervention Interview From
time frame: Immediately upon Completion of the patient's infusion
description: After the patients' infusion they will be asked questions from this form
arm group label: Peppermint and Lavender Essential Oil
arm group type: Experimental
description: Young Living Essential oil of Peppermint and Lavender will be used to patients who meet the inclusion criteria.
intervention type: Other
intervention name: Young Living Lavender Essential Oil
description: For qualified patients one to two drops of hospital approved essential oil will be placed on a 4X4 gauze and will be offered to the patient during their infusion visit. This gauze will be placed in a sealable clear plastic bag and the patient will be instructed to use one sniff at a time.
arm group label: Peppermint and Lavender Essential Oil
other name: Young Living Peppermint Essential Oil
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lorraine Mack, MSN
role: Principal Investigator
affiliation: Central DuPage Hospital
last name: Lorraine Mack, MSN
phone: 630-315-6025
email: lorraine.mack@nm.org
last name: Megha Shah, BSN
email: megha.shah@nm.org
facility: 
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Nausea
sharing ipd: No