<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/NCT03228147</url>
  </required_header>
  <id_info>
    <org_study_id>071701</org_study_id>
    <secondary_id>NCI-2017-01151</secondary_id>
    <secondary_id>Pro20170000485</secondary_id>
    <secondary_id>071701</secondary_id>
    <secondary_id>P30CA072720</secondary_id>
    <nct_id>NCT03228147</nct_id>
  </id_info>
  <brief_title>Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment</brief_title>
  <official_title>Sensory Evaluation of a New Oral Nutrition Supplement in Patients at Risk for Mucositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</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>
      This pilot clinical trial studies sensory evaluation of oral nutrition supplements in&#xD;
      patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to&#xD;
      obtain input about new oral nutritional supplements that may increase nutrient intake and&#xD;
      maintain or improve nutritional status, functional capacity, and quality of life in cancer&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To identify two products (one from the creamy shake category and one from the tea&#xD;
      category) with the highest total average score that will be selected to move onto further&#xD;
      testing.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive 10 different nutrition supplements orally (PO) and complete questionnaires&#xD;
      based on each sample in a single session over 60-90 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A creamy shake product with the highest total average nutrition supplement scores as assessed by questionnaires</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will identify one product from the creamy shake category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A tea product with the highest total average nutrition supplement scores as assessed by questionnaires</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will identify one product from the tea category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (Cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Esophagitis</condition>
  <condition>Malignant Neoplasm</condition>
  <condition>Mucositis</condition>
  <arm_group>
    <arm_group_label>Supportive Care (nutrition supplement)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 10 different nutrition supplements PO and complete questionnaires based on each sample in a single session over 60-90 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutritional Supplementation</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Supportive Care (nutrition supplement)</arm_group_label>
    <other_name>Supplementation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (nutrition supplement)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing cancer treatment (chemotherapy, radiotherapy, and/or immunotherapy)&#xD;
&#xD;
          -  At risk for mucositis OR with stage I mucositis or esophagitis (i.e. radiotherapy to&#xD;
             the head, neck, esophagus or lung OR treatment with fluorouracil (5-FU) or other&#xD;
             chemotherapeutic agents that are known to cause mucositis or esophagitis) or at risk&#xD;
             for xerostomia&#xD;
&#xD;
          -  Within the first 3 weeks of initiation of a new type of therapy&#xD;
&#xD;
          -  Able to read and write in English&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food allergy to any component of the supplement&#xD;
&#xD;
          -  Inability to taste or smell due to medication or health condition&#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>Salma Jabbour</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Cancer Institute of New Jersey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</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>Neoplasms</mesh_term>
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Esophagitis</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/NCT03228147
org study id: 071701
secondary id: NCI-2017-01151
secondary id: Pro20170000485
secondary id: 071701
secondary id: P30CA072720
nct id: NCT03228147
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This pilot clinical trial studies sensory evaluation of oral nutrition supplements in
      patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to
      obtain input about new oral nutritional supplements that may increase nutrient intake and
      maintain or improve nutritional status, functional capacity, and quality of life in cancer
      patients.
PRIMARY OBJECTIVES:

      I. To identify two products (one from the creamy shake category and one from the tea
      category) with the highest total average score that will be selected to move onto further
      testing.

      OUTLINE:

      Patients receive 10 different nutrition supplements orally (PO) and complete questionnaires
      based on each sample in a single session over 60-90 minutes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: A creamy shake product with the highest total average nutrition supplement scores as assessed by questionnaires
time frame: Up to 1 year
description: Will identify one product from the creamy shake category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale.
measure: A tea product with the highest total average nutrition supplement scores as assessed by questionnaires
time frame: Up to 1 year
description: Will identify one product from the tea category with the highest total average score that will be selected to move onto further testing. The subjective assessments of each formula will be assessed and mean, standard deviation and range will be calculated for each response. There will be subjective evaluation of acceptance of the overall sensory attributes and flavor liking (9-point scale), open-ended description of sensory attributes and effects (aroma, flavor, aftertaste, off-flavors), flavor intensity, sweetness (too little, just about right, too thick) 5-point scale. In-mouth sensations (Cooling, tingling, mouth wetting, refreshing, soothing, wetting) 9-point scale.
arm group label: Supportive Care (nutrition supplement)
arm group type: Experimental
description: Patients receive 10 different nutrition supplements PO and complete questionnaires based on each sample in a single session over 60-90 minutes.
intervention type: Dietary Supplement
intervention name: Nutritional Supplementation
description: Given PO
arm group label: Supportive Care (nutrition supplement)
other name: Supplementation
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive Care (nutrition supplement)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Salma Jabbour
role: Principal Investigator
affiliation: Rutgers Cancer Institute of New Jersey
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Mucositis
mesh term: Esophagitis