<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/NCT04436965</url>
  </required_header>
  <id_info>
    <org_study_id>2019-FXY-348-NPC</org_study_id>
    <nct_id>NCT04436965</nct_id>
  </id_info>
  <brief_title>Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition</brief_title>
  <official_title>Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wuhan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jiangxi Provincial Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Hospital of Guizhou Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</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 is a multicenter, randomized controlled, phase III clinical trial. The purpose of this&#xD;
      study is to evaluate the efficacy of standard nutrition treatment versus conventional&#xD;
      nutrition treatment in local advanced nasopharyngeal carcinoma patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 16, 2021</start_date>
  <completion_date type="Anticipated">December 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2024</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of IBW%</measure>
    <time_frame>2 months</time_frame>
    <description>To observe the changes and differences in the incidence of the actual weight/ideal weight (IBW%) less than 90% during the treatment of the two groups of patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of WL、UBW% and BMI</measure>
    <time_frame>36 months</time_frame>
    <description>To observe the changes and differences in the incidence of body weight loss (WL)≥5%/10%, actual body weight/usual body weight (UBW%), body mass index (BMI) before, during and after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Laboratory Values</measure>
    <time_frame>36 months</time_frame>
    <description>To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>36 months</time_frame>
    <description>From date of recruited to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>36 months</time_frame>
    <description>From date of recruited to disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional recurrence free survival</measure>
    <time_frame>36 months</time_frame>
    <description>From date of recruited to locoregional recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis free survival</measure>
    <time_frame>36 months</time_frame>
    <description>From date of recruited to distant metastasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition screening and evaluation</measure>
    <time_frame>36 months</time_frame>
    <description>To observe the changes and differences of nutrition screening and evaluation (NRS2002 and PG-SGA) before, during and after treatment in the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: EuroQoL 5 dimension</measure>
    <time_frame>36 months</time_frame>
    <description>Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute toxicities</measure>
    <time_frame>through study completion, an average of 2 months</time_frame>
    <description>Evaluating with CTCAE v5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late toxicity</measure>
    <time_frame>36 months</time_frame>
    <description>assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">266</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <condition>Nutrition Therapy</condition>
  <arm_group>
    <arm_group_label>Standard nutrition therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional nutrition therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standardized nutrition therapy</intervention_name>
    <description>Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition</description>
    <arm_group_label>Standard nutrition therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.</description>
    <arm_group_label>Conventional nutrition therapy</arm_group_label>
    <arm_group_label>Standard nutrition therapy</arm_group_label>
    <other_name>DDP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity Modulated Radiation Therapy</intervention_name>
    <description>Patients in both arms received Intensity Modulated Radiation Therapy:All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose was 70-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-70 Gy to PTVnd (Planning target volume of the cervical lymph node),60- 64Gy to PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).</description>
    <arm_group_label>Conventional nutrition therapy</arm_group_label>
    <arm_group_label>Standard nutrition therapy</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);&#xD;
&#xD;
          -  All genders，range from 18～65 years old;&#xD;
&#xD;
          -  Karnofsky performance status(KPS) ≥ 80;&#xD;
&#xD;
          -  Clinical stage III~IVa(AJCC/UICC 8th);&#xD;
&#xD;
          -  Without significant digestive system disease，nutritional and metabolic diseases or&#xD;
             endocrine disease&#xD;
&#xD;
          -  Without significant cardiac，respiratory，kidney or liver disease;&#xD;
&#xD;
          -  Not received radiotherapy, chemotherapy and other anti-tumor treatment(including&#xD;
             immunotherapy);&#xD;
&#xD;
          -  White blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L,&#xD;
             Hemoglobin(HGB) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L&#xD;
&#xD;
          -  Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate&#xD;
             aminotransferase(AST) &lt; 2.5×upper limit of normal(ULN);&#xD;
&#xD;
          -  Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥&#xD;
             60ml/min (Cockcroft-Gault formula);&#xD;
&#xD;
          -  No contraindications to chemotherapy or radiotherapy;&#xD;
&#xD;
          -  Inform consent form;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant&#xD;
             medications and aspirin, gastric ulcer or history of gastric bleeding, portal&#xD;
             hypertension combined with abdominal and esophageal fundal varices, pyloric&#xD;
             obstruction due to residual stomach under the costal arch after various major&#xD;
             gastrectomy or various reasons;&#xD;
&#xD;
          -  Distance metastases;&#xD;
&#xD;
          -  Have or are suffering from other malignant tumors;&#xD;
&#xD;
          -  Participating in other clinical trials;&#xD;
&#xD;
          -  Drug or alcohol addition;&#xD;
&#xD;
          -  Do not have full capacity for civil acts;&#xD;
&#xD;
          -  Mental disorder;&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Severe complication, eg, uncontrolled hypertension;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chong Zhao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jingjing Miao, MD</last_name>
    <phone>86-13631355201</phone>
    <email>miaojingjing90@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chong Zhao, MD</last_name>
      <phone>02087342638</phone>
      <email>zhaochong@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.sysucc.org.cn</url>
    <description>Home Page of Cancer Center, Sun Yat-sen University</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 29, 2023</last_update_submitted>
  <last_update_submitted_qc>January 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Zhao Chong</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_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/NCT04436965
org study id: 2019-FXY-348-NPC
nct id: NCT04436965
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this
      study is to evaluate the efficacy of standard nutrition treatment versus conventional
      nutrition treatment in local advanced nasopharyngeal carcinoma patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The incidence of IBW%
time frame: 2 months
description: To observe the changes and differences in the incidence of the actual weight/ideal weight (IBW%) less than 90% during the treatment of the two groups of patients
measure: The incidence of WL、UBW% and BMI
time frame: 36 months
description: To observe the changes and differences in the incidence of body weight loss (WL)≥5%/10%, actual body weight/usual body weight (UBW%), body mass index (BMI) before, during and after treatment
measure: Number of Participants With Abnormal Laboratory Values
time frame: 36 months
description: To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.
measure: Overall survival
time frame: 36 months
description: From date of recruited to death
measure: Progression free survival
time frame: 36 months
description: From date of recruited to disease progression
measure: Locoregional recurrence free survival
time frame: 36 months
description: From date of recruited to locoregional recurrence
measure: Distant metastasis free survival
time frame: 36 months
description: From date of recruited to distant metastasis
measure: Nutrition screening and evaluation
time frame: 36 months
description: To observe the changes and differences of nutrition screening and evaluation (NRS2002 and PG-SGA) before, during and after treatment in the two groups
measure: Quality of life: EuroQoL 5 dimension
time frame: 36 months
description: Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
measure: Acute toxicities
time frame: through study completion, an average of 2 months
description: Evaluating with CTCAE v5.0
measure: Late toxicity
time frame: 36 months
description: assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria
arm group label: Standard nutrition therapy
arm group type: Experimental
description: Dynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.
arm group label: Conventional nutrition therapy
arm group type: Active Comparator
description: Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.
intervention type: Other
intervention name: Standardized nutrition therapy
description: Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition
arm group label: Standard nutrition therapy
intervention type: Drug
intervention name: Cisplatin
description: Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.
arm group label: Conventional nutrition therapy
arm group label: Standard nutrition therapy
other name: DDP
intervention type: Radiation
intervention name: Intensity Modulated Radiation Therapy
description: Patients in both arms received Intensity Modulated Radiation Therapy:All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose was 70-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-70 Gy to PTVnd (Planning target volume of the cervical lymph node),60- 64Gy to PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
arm group label: Conventional nutrition therapy
arm group label: Standard nutrition therapy
other name: IMRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chong Zhao, MD
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Jingjing Miao, MD
phone: 86-13631355201
email: miaojingjing90@163.com
facility: 
status: Recruiting
contact: 
country: China
url: http://www.sysucc.org.cn
description: Home Page of Cancer Center, Sun Yat-sen University
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Zhao Chong
investigator title: Prof.
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Malnutrition
mesh term: Cisplatin