<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/NCT03286920</url>
  </required_header>
  <id_info>
    <org_study_id>2017-06-01</org_study_id>
    <nct_id>NCT03286920</nct_id>
  </id_info>
  <brief_title>Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer</brief_title>
  <official_title>Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anyang Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Bengbu Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanxi Province Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaoning Tumor Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan General Hospital of Guangzhou Military Command</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hunan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Union hospital of Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is designed to be a multi-center prospective observational study which&#xD;
      shall compare the effect of different postoperative home nutrition modes on recent&#xD;
      nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes.&#xD;
      Different postoperative home nutrition modes adopted in this study includes oral natural&#xD;
      diet, oral nutrition supplement and tube feeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY BACKGROUND Esophageal cancer is a common cancer in China and due to its influence on&#xD;
      diet intake, patients with esophageal cancer are often combined with nutrition deficiency,&#xD;
      which causes relatively high nutrition risk to treatment. Studies conducted by Martin et al&#xD;
      showed that the degree of body weight loss in patients with malignancy is related to BMI&#xD;
      level and prognosis. The patients with severe body weight loss and low BMI have poor&#xD;
      prognosis, especially for patients with esophageal cancer.&#xD;
&#xD;
      At present, perioperative nutrition support for patients with esophageal cancer has been&#xD;
      recognized and has been recommended as routine in 2017 NCCN guideline. How to implement good&#xD;
      home nutrition within one month after patient discharge and recover nutrition index as soon&#xD;
      as possible has become a focus for esophageal surgeon.&#xD;
&#xD;
      Many clinical trials have already investigated enteral nutrition support approach during&#xD;
      anti-cancer treatment period in patients with malignancy. However, only a few clinical trials&#xD;
      are good designed. Therefore the investigators hope to via this multi-center prospective&#xD;
      observational study to provide evidence for this question.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
        1. To explore the relationship between postoperative home nutrition support treatment&#xD;
           approach and nutritional status of patients with esophageal cancer;&#xD;
&#xD;
        2. To explore the relationship between postoperative home nutrition support treatment&#xD;
           approach and recent prognosis in patients with esophageal cancer;&#xD;
&#xD;
        3. To promote the standardized application of postoperative home nutrition support&#xD;
           treatment for patients with esophageal cancer.\&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Included patients shall be divided into three groups according to the treatment plan of all&#xD;
      centers, including oral natural diet, oral nutrition supplement and tube feeding. As for&#xD;
      patients in oral natural diet group, the patients shall receive oral natural diet. As for&#xD;
      patients in oral nutrition supplement group, in addition to oral natural die, the&#xD;
      participants shall receive oral enteral supplement providing 750-1500kcal/d. As for patients&#xD;
      in tube feeding group, in addition to oral natural die, the participants shall receive tube&#xD;
      feeding enteral supplement providing 750-1500kcal/d.&#xD;
&#xD;
      All the included patients shall be followed up weekly within 1-3 weeks after discharge via&#xD;
      telephone, at Day 30 after discharge and at Day 90 after discharge to assess the&#xD;
      effectiveness and safety of different home nutrition supplement approaches.&#xD;
&#xD;
      PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>Percentage of 5% body weight loss on Day 30</measure>
    <time_frame>Day 30 after discharge</time_frame>
    <description>Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Completion ratio of different nutrition support approaches</measure>
    <time_frame>Day 30 after discharge</time_frame>
    <description>Completion ratio of different nutrition support approaches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale</measure>
    <time_frame>Day30 and Day 90</time_frame>
    <description>Assessment on patients' quality of life using EORTC QLQ-C30 scale and QLQ-OG25 scale in different nutrition support approach groups and investigate the relationship between different nutrition support approaches and patients' quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of home enteral nutrition support</measure>
    <time_frame>Day30</time_frame>
    <description>Assessment on complications of home enteral nutrition support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay and interruption ratio of adjuvant treatment</measure>
    <time_frame>Day 30 and Day 90</time_frame>
    <description>Delay and interruption ratio of adjuvant treatment including whether chemotherapy and radiotherapy can be implemented on time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-hospitalization ratio</measure>
    <time_frame>Day 90</time_frame>
    <description>Re-hospitalization ratio within 90 days after discharge</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>Oral natural diet</arm_group_label>
    <description>As for patients in oral natural diet group, the the participants shall receive oral natural diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral nutrition supplement group</arm_group_label>
    <description>As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tube feeding nutrition supplement group</arm_group_label>
    <description>As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding nutrition supplement providing 750-1500kcal/d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral nutrition supplement</intervention_name>
    <description>As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.</description>
    <arm_group_label>Oral nutrition supplement group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tube feeding nutrition supplement</intervention_name>
    <description>As for patients in tube feeding group, in addition to oral natural die, the participants shall receive Tube feeding nutrition supplement providing 750-1500kcal/d.</description>
    <arm_group_label>Tube feeding nutrition supplement group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with esophageal cancer who undergo surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age below 80 years old;&#xD;
&#xD;
          -  Esophageal cancer;&#xD;
&#xD;
          -  Radical surgery;&#xD;
&#xD;
          -  Normal gastrointestinal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with diabetes and poor blood glucose control;&#xD;
&#xD;
          -  Patients with severe postoperative complications;&#xD;
&#xD;
          -  Patients who can't tolerate lactose;&#xD;
&#xD;
          -  Patients who decline inclusion and follow-ups&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keneng Chen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Keneng Chen, M.D.</last_name>
    <phone>+86 13501085973</phone>
    <email>chenkeneng@bjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Liang Dai, M.D.</last_name>
    <phone>+86 18610065191</phone>
    <email>dailiangsharp_26@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First Affiliated Hospital Bengbu Medical College</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Geng, Master</last_name>
      <phone>+86 15755235970</phone>
      <email>495922402@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zaicheng Yu, Master</last_name>
      <phone>+86 13705699600</phone>
      <email>13705699600@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Renquan Zhang, Master</last_name>
      <phone>+86 13505693475</phone>
      <email>zhangrenquan@live.cn</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keneng Chen, M.D.</last_name>
      <phone>+86 13501085973</phone>
      <email>chenkeneng@bjmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Liang Dai, M.D.</last_name>
      <phone>+86 18610065191</phone>
      <email>dailiangsharp_26@aliyun.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>China-Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Deruo Liu, M.D.</last_name>
      <phone>+86 13801186957</phone>
      <email>fenghongxiang617@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhipeng Ren, M.D.</last_name>
      <phone>+86 15901297308</phone>
      <email>renzhipeng04@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Guo, M.D.</last_name>
      <phone>+86 13527323568</phone>
      <email>gyguowei@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Union hospital of Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chun Chen, M.D.</last_name>
      <phone>+86 13365910325</phone>
      <email>chenchun0209@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Hospital</name>
      <address>
        <city>Guangdong</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenfeng Ye, M.D.</last_name>
      <phone>+86 13902266462</phone>
      <email>gzyewf@hotmai.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangzhou General Hospital of Guangzhou Military Command</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guibin Qiao, M.D.</last_name>
      <phone>+86 13602749153</phone>
      <email>guibinqiao@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hebei Medical University Fourth Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming He, M.D.</last_name>
      <phone>+86 13833187902</phone>
      <email>heming6699@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianqun Ma, M.D.</last_name>
      <phone>+86 13359990466</phone>
      <email>jianqunma@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Anyang Tumor Hospital</name>
      <address>
        <city>Anyang</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaotian Shi, M.D.</last_name>
      <phone>+86 13703725817</phone>
      <email>shxt531216sh@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangning Fu, M.D.</last_name>
      <phone>+86 13607150390</phone>
      <email>fuxn2006@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenliang Liu, M.D.</last_name>
      <phone>+86 13507438708</phone>
      <email>liuwenliang1859@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youbin Cui, M.D.</last_name>
      <phone>+86 13364513508</phone>
      <email>cuiyb@jlu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Liaoning Tumor Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongxu Liu, M.D.</last_name>
      <phone>+86 13840004476</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Tian, M.D.</last_name>
      <phone>+86 13791122838</phone>
      <email>tianhuiql@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhou Wang, M.D.</last_name>
      <phone>+86 13665312567</phone>
      <email>wz620226@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fudan University Cancer Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Hu, Master</last_name>
      <phone>+86 13512102066</phone>
      <email>huhong0997@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhigang Li, M.D.</last_name>
      <phone>+86 13816121518</phone>
      <email>dr_lizhigang@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Province Cancer Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiping Guo, Master</last_name>
      <phone>+86 13700541808</phone>
      <email>chunhua527@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First People's Hospital of Yunan province</name>
      <address>
        <city>Kunming</city>
        <state>Yunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang Bu, M.D.</last_name>
      <phone>+86 13611000133</phone>
      <email>thoracicsurgeon@vip.sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qixun Chen, M.D&gt;</last_name>
      <phone>+86 13958108371</phone>
      <email>chenqixun64@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Ke-Neng Chen, MD, PhD, FRCS</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>home nutrition</keyword>
  <keyword>BMI</keyword>
  <keyword>postoperative</keyword>
  <keyword>body weight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal 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/NCT03286920
org study id: 2017-06-01
nct id: NCT03286920
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has dmc: No
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This clinical trial is designed to be a multi-center prospective observational study which
      shall compare the effect of different postoperative home nutrition modes on recent
      nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes.
      Different postoperative home nutrition modes adopted in this study includes oral natural
      diet, oral nutrition supplement and tube feeding.
STUDY BACKGROUND Esophageal cancer is a common cancer in China and due to its influence on
      diet intake, patients with esophageal cancer are often combined with nutrition deficiency,
      which causes relatively high nutrition risk to treatment. Studies conducted by Martin et al
      showed that the degree of body weight loss in patients with malignancy is related to BMI
      level and prognosis. The patients with severe body weight loss and low BMI have poor
      prognosis, especially for patients with esophageal cancer.

      At present, perioperative nutrition support for patients with esophageal cancer has been
      recognized and has been recommended as routine in 2017 NCCN guideline. How to implement good
      home nutrition within one month after patient discharge and recover nutrition index as soon
      as possible has become a focus for esophageal surgeon.

      Many clinical trials have already investigated enteral nutrition support approach during
      anti-cancer treatment period in patients with malignancy. However, only a few clinical trials
      are good designed. Therefore the investigators hope to via this multi-center prospective
      observational study to provide evidence for this question.

      OBJECTIVES:

        1. To explore the relationship between postoperative home nutrition support treatment
           approach and nutritional status of patients with esophageal cancer;

        2. To explore the relationship between postoperative home nutrition support treatment
           approach and recent prognosis in patients with esophageal cancer;

        3. To promote the standardized application of postoperative home nutrition support
           treatment for patients with esophageal cancer.\

      OUTLINE:

      Included patients shall be divided into three groups according to the treatment plan of all
      centers, including oral natural diet, oral nutrition supplement and tube feeding. As for
      patients in oral natural diet group, the patients shall receive oral natural diet. As for
      patients in oral nutrition supplement group, in addition to oral natural die, the
      participants shall receive oral enteral supplement providing 750-1500kcal/d. As for patients
      in tube feeding group, in addition to oral natural die, the participants shall receive tube
      feeding enteral supplement providing 750-1500kcal/d.

      All the included patients shall be followed up weekly within 1-3 weeks after discharge via
      telephone, at Day 30 after discharge and at Day 90 after discharge to assess the
      effectiveness and safety of different home nutrition supplement approaches.

      PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
observational model: Cohort
time perspective: Prospective
measure: Percentage of 5% body weight loss on Day 30
time frame: Day 30 after discharge
description: Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
measure: Completion ratio of different nutrition support approaches
time frame: Day 30 after discharge
description: Completion ratio of different nutrition support approaches
measure: Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale
time frame: Day30 and Day 90
description: Assessment on patients' quality of life using EORTC QLQ-C30 scale and QLQ-OG25 scale in different nutrition support approach groups and investigate the relationship between different nutrition support approaches and patients' quality of life
measure: Complications of home enteral nutrition support
time frame: Day30
description: Assessment on complications of home enteral nutrition support
measure: Delay and interruption ratio of adjuvant treatment
time frame: Day 30 and Day 90
description: Delay and interruption ratio of adjuvant treatment including whether chemotherapy and radiotherapy can be implemented on time
measure: Re-hospitalization ratio
time frame: Day 90
description: Re-hospitalization ratio within 90 days after discharge
arm group label: Oral natural diet
description: As for patients in oral natural diet group, the the participants shall receive oral natural diet.
arm group label: Oral nutrition supplement group
description: As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
arm group label: Tube feeding nutrition supplement group
description: As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding nutrition supplement providing 750-1500kcal/d.
intervention type: Dietary Supplement
intervention name: Oral nutrition supplement
description: As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
arm group label: Oral nutrition supplement group
intervention type: Dietary Supplement
intervention name: Tube feeding nutrition supplement
description: As for patients in tube feeding group, in addition to oral natural die, the participants shall receive Tube feeding nutrition supplement providing 750-1500kcal/d.
arm group label: Tube feeding nutrition supplement group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 80 Years
healthy volunteers: No
last name: Keneng Chen, M.D.
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Keneng Chen, M.D.
phone: +86 13501085973
email: chenkeneng@bjmu.edu.cn
last name: Liang Dai, M.D.
phone: +86 18610065191
email: dailiangsharp_26@aliyun.com
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country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Ke-Neng Chen, MD, PhD, FRCS
investigator title: Doctor
mesh term: Esophageal Neoplasms
sharing ipd: No