<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/NCT04495387</url>
  </required_header>
  <id_info>
    <org_study_id>ALTERTASTE</org_study_id>
    <nct_id>NCT04495387</nct_id>
  </id_info>
  <brief_title>Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy</brief_title>
  <official_title>Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florence</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florence</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>
      The global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (WHO),&#xD;
      with a trend of ongoing growth. This very frequent illness exerts tremendous physical,&#xD;
      emotional and financial strain on individuals, families, communities and health systems.&#xD;
&#xD;
      Malnutrition (under- or over-nutrition) is highly prevalent in cancer patients receiving&#xD;
      chemotherapy and is an important predictor of morbidity, mortality, treatment response and&#xD;
      toxicity. Alterations in taste and smell are frequently reported as side effect of&#xD;
      chemotherapy and may contribute strongly to malnutrition and to a worsen quality of life and&#xD;
      wellbeing social, emotional, and role functioning. There are evidences that chemotherapy&#xD;
      influences food liking and appetite with implications for food behaviours, including food&#xD;
      enjoyment, food preference and dietary intake. A linkage between alterations in taste and /or&#xD;
      smell and food behaviours has been reported by some studies but not all, suggesting that&#xD;
      there is a need for more research using common standardised methodologies and larger sample&#xD;
      size to gain a further insight into this topic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change of taste chemotherapy-related alterations</measure>
    <time_frame>the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)</time_frame>
    <description>To better understand alteration of taste/smell and food behaviours by the self-report responses, using an adapted version of a questionnaire set up to measure taste changes due to COVID-19</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotions elicited by foods</measure>
    <time_frame>the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)</time_frame>
    <description>Emotions elicited by foods will be measured on a selection of foods through an EmoSemio questionnaire, a self-report measure of emotion developed based on preliminary interviews</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Breast Cancer</condition>
  <condition>Chemotherapeutic Toxicity</condition>
  <arm_group>
    <arm_group_label>patients with colon cancer</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with breast cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>standard adjuvat chemotherapy for reast and colo cancer</description>
    <arm_group_label>patients with breast cancer</arm_group_label>
    <arm_group_label>patients with colon cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data will be collected on patients that are receiving chemotherapy for breast (n=50) and&#xD;
        colorectal cancer (n=50) as adjuvant or neo-adjuvant therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pathological diagnosis of colorectal or breast cacer&#xD;
&#xD;
          -  indication to adjuvant chemotherapy for colon cancer according local guide lines&#xD;
&#xD;
          -  indication to (neo)-adjuvant chemotherapy for reast cancer according local guide lines&#xD;
&#xD;
          -  possiility to sign an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients aged &lt;18 years&#xD;
&#xD;
          -  patients aged &gt;80 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Florence</investigator_affiliation>
    <investigator_full_name>Giandomenico Roviello</investigator_full_name>
    <investigator_title>Assistant professor, md, phd</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04495387
org study id: ALTERTASTE
nct id: NCT04495387
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (WHO),
      with a trend of ongoing growth. This very frequent illness exerts tremendous physical,
      emotional and financial strain on individuals, families, communities and health systems.

      Malnutrition (under- or over-nutrition) is highly prevalent in cancer patients receiving
      chemotherapy and is an important predictor of morbidity, mortality, treatment response and
      toxicity. Alterations in taste and smell are frequently reported as side effect of
      chemotherapy and may contribute strongly to malnutrition and to a worsen quality of life and
      wellbeing social, emotional, and role functioning. There are evidences that chemotherapy
      influences food liking and appetite with implications for food behaviours, including food
      enjoyment, food preference and dietary intake. A linkage between alterations in taste and /or
      smell and food behaviours has been reported by some studies but not all, suggesting that
      there is a need for more research using common standardised methodologies and larger sample
      size to gain a further insight into this topic.
observational model: Cohort
time perspective: Prospective
measure: change of taste chemotherapy-related alterations
time frame: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)
description: To better understand alteration of taste/smell and food behaviours by the self-report responses, using an adapted version of a questionnaire set up to measure taste changes due to COVID-19
measure: Emotions elicited by foods
time frame: the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)
description: Emotions elicited by foods will be measured on a selection of foods through an EmoSemio questionnaire, a self-report measure of emotion developed based on preliminary interviews
arm group label: patients with colon cancer
arm group label: patients with breast cancer
intervention type: Drug
intervention name: Chemotherapy
description: standard adjuvat chemotherapy for reast and colo cancer
arm group label: patients with breast cancer
arm group label: patients with colon cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Florence
investigator full name: Giandomenico Roviello
investigator title: Assistant professor, md, phd
mesh term: Colonic Neoplasms
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)