<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/NCT03034603</url>
  </required_header>
  <id_info>
    <org_study_id>DIF-04</org_study_id>
    <nct_id>NCT03034603</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients</brief_title>
  <official_title>The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dental Innovation Foundation Under Royal Patronage</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Srinakharinwirot University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dental Innovation Foundation Under Royal Patronage</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This triple-blinded randomized placebo control trial aims to investigate the safety and&#xD;
      efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The&#xD;
      primary outcome measure includes adverse events, health-related quality of life, tumor&#xD;
      response and progression-free survival. The secondary outcome includes serum p53 and&#xD;
      cytochrome C levels and functional status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previously, Nutri-jelly, a novel edible nutritious gel for patients with chewing and&#xD;
      swallowing difficulties, was shown to be effective in improving the quality of life of head&#xD;
      and neck cancer patients. Recently, Nutri-PEITC jelly is recently developed by addition of&#xD;
      Phenethyl Isothiocyanate (PEITC), a phytochemical compound with chemopreventive action in&#xD;
      animal bearing oral cancer. It intends to be a functional food for cancer survivor. The dose&#xD;
      of PEITC in Nutri-jelly was based on safe and effective dose determined in animal studies.&#xD;
      Furthermore, Nutri-PEITC jelly was proven safe in healthy volunteers who daily consumes for a&#xD;
      consecutive month with no serious adverse events. The purpose of this study is to determine&#xD;
      safety and efficacy of Nutri-jelly with PEITC in head and neck cancer patients.&#xD;
&#xD;
      independent variable: continuous Nutri -jelly with PEITC intake dependent variable (outcome):&#xD;
      adverse effects, health-related quality of life score, tumor response, progression-free&#xD;
      survival, serum p53 and cytochrome C levels and functional status&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">January 2023</completion_date>
  <primary_completion_date type="Actual">February 2021</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 month and 3 months after receiving intervention</time_frame>
    <description>Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Health-related quality of life score compared to baseline</measure>
    <time_frame>Baseline, 1 month and 3 months after receiving intervention</time_frame>
    <description>Evaluation of Health-related quality of life by using questionnaire FACT-HN</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Tumor response compared to baseline</measure>
    <time_frame>Baseline, 1 month, 3 months after receiving intervention</time_frame>
    <description>Evaluation of tumor response following RECIST criteria at 1 month and 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free survival time</measure>
    <time_frame>The time of the intervention until any signs or symptoms of progressive disease be recorded.</time_frame>
    <description>The length of time during the intervention that the participant lives with stable disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum p53 level</measure>
    <time_frame>1 month and 3 months after receiving intervention</time_frame>
    <description>Level of both wild type and mutant p53 in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cytochrome C level</measure>
    <time_frame>1 month and 3 months after receiving intervention</time_frame>
    <description>Level of cytochrome C in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Functional status</measure>
    <time_frame>Baseline, 1 month and 3 months after receiving intervention</time_frame>
    <description>Evaluation of functional status using KPS (Karnofsky Performance Score) score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <condition>Quality of Life</condition>
  <condition>Nutrition Related Cancer</condition>
  <arm_group>
    <arm_group_label>Nutri-jelly with PEITC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutri-jelly</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutri-jelly with PEITC</intervention_name>
    <description>Nutri-jelly with PEITC resulted from an addition of tested amount of PEITC, which was shown in animal model to delay cancer growth, into Nutri-jelly.</description>
    <arm_group_label>Nutri-jelly with PEITC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutri-jelly</intervention_name>
    <description>Nutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal.</description>
    <arm_group_label>Nutri-jelly</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and&#xD;
             hypopharynx, who receive only palliative care or deny definitive treatment&#xD;
&#xD;
          2. Finished radiotherapy or/and chemotherapy for at least one month&#xD;
&#xD;
          3. Has at least one measurable target lesion&#xD;
&#xD;
          4. Baseline KPS ≥ 40% or ECOG 0-3&#xD;
&#xD;
          5. Blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x&#xD;
             109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula&#xD;
             (Chronic Kidney Disease Epidemiology group) ≥50 mL/min) and hepatic function (SGOT ,&#xD;
             SGPT, serum bilirubin ≤ 1.5 of upper limits of normal&#xD;
&#xD;
          6. Able to take the intervention (through mouth or NG tube) without aspiration&#xD;
&#xD;
          7. Able to communicate and consent to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cannot come back for the follow-up visits&#xD;
&#xD;
          2. Receive or had received N-acetylcysteine during the intervention&#xD;
&#xD;
          3. Has systemic diseases that might interfere with the results&#xD;
&#xD;
          4. Chronic kidney disease that requires dialysis&#xD;
&#xD;
          5. Increased risk of aspiration pneumonia&#xD;
&#xD;
          6. Pregnancy or lactation&#xD;
&#xD;
          7. Untreated infectious diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aroonwan Lam-ubol, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Srinakharinwirot University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National cancer institute</name>
      <address>
        <city>Bankok</city>
        <state>Bangkok</state>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonburi Cancer Hospital</name>
      <address>
        <city>Cholburi</city>
        <state>Chonburi</state>
        <zip>20000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lopburi Cancer Hospital</name>
      <address>
        <city>Lopburi</city>
        <zip>15000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maharat Nakhon Ratchasima Hospital</name>
      <address>
        <city>Nakhon Ratchasima</city>
        <zip>30000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maha Vajiralongkorn Thanyaburi Hospital</name>
      <address>
        <city>Pathum Thani</city>
        <zip>12110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</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>Head and Neck Neoplasms</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/NCT03034603
org study id: DIF-04
nct id: NCT03034603
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This triple-blinded randomized placebo control trial aims to investigate the safety and
      efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The
      primary outcome measure includes adverse events, health-related quality of life, tumor
      response and progression-free survival. The secondary outcome includes serum p53 and
      cytochrome C levels and functional status.
Previously, Nutri-jelly, a novel edible nutritious gel for patients with chewing and
      swallowing difficulties, was shown to be effective in improving the quality of life of head
      and neck cancer patients. Recently, Nutri-PEITC jelly is recently developed by addition of
      Phenethyl Isothiocyanate (PEITC), a phytochemical compound with chemopreventive action in
      animal bearing oral cancer. It intends to be a functional food for cancer survivor. The dose
      of PEITC in Nutri-jelly was based on safe and effective dose determined in animal studies.
      Furthermore, Nutri-PEITC jelly was proven safe in healthy volunteers who daily consumes for a
      consecutive month with no serious adverse events. The purpose of this study is to determine
      safety and efficacy of Nutri-jelly with PEITC in head and neck cancer patients.

      independent variable: continuous Nutri -jelly with PEITC intake dependent variable (outcome):
      adverse effects, health-related quality of life score, tumor response, progression-free
      survival, serum p53 and cytochrome C levels and functional status
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events
time frame: 1 month and 3 months after receiving intervention
description: Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects
measure: Changes in Health-related quality of life score compared to baseline
time frame: Baseline, 1 month and 3 months after receiving intervention
description: Evaluation of Health-related quality of life by using questionnaire FACT-HN
measure: Changes in Tumor response compared to baseline
time frame: Baseline, 1 month, 3 months after receiving intervention
description: Evaluation of tumor response following RECIST criteria at 1 month and 3 months
measure: Progression-free survival time
time frame: The time of the intervention until any signs or symptoms of progressive disease be recorded.
description: The length of time during the intervention that the participant lives with stable disease
measure: Serum p53 level
time frame: 1 month and 3 months after receiving intervention
description: Level of both wild type and mutant p53 in serum
measure: Serum cytochrome C level
time frame: 1 month and 3 months after receiving intervention
description: Level of cytochrome C in serum
measure: Changes in Functional status
time frame: Baseline, 1 month and 3 months after receiving intervention
description: Evaluation of functional status using KPS (Karnofsky Performance Score) score
arm group label: Nutri-jelly with PEITC
arm group type: Experimental
description: Continuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months.
arm group label: Nutri-jelly
arm group type: Placebo Comparator
description: Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months.
intervention type: Dietary Supplement
intervention name: Nutri-jelly with PEITC
description: Nutri-jelly with PEITC resulted from an addition of tested amount of PEITC, which was shown in animal model to delay cancer growth, into Nutri-jelly.
arm group label: Nutri-jelly with PEITC
intervention type: Dietary Supplement
intervention name: Nutri-jelly
description: Nutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal.
arm group label: Nutri-jelly
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Aroonwan Lam-ubol, DDS, PhD
role: Principal Investigator
affiliation: Srinakharinwirot University
facility: 
facility: 
facility: 
facility: 
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: No