- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286920
Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- To explore the relationship between postoperative home nutrition support treatment approach and nutritional status of patients with esophageal cancer;
- To explore the relationship between postoperative home nutrition support treatment approach and recent prognosis in patients with esophageal cancer;
- 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Keneng Chen, M.D.
- Phone Number: +86 13501085973
- Email: chenkeneng@bjmu.edu.cn
Study Contact Backup
- Name: Liang Dai, M.D.
- Phone Number: +86 18610065191
- Email: dailiangsharp_26@aliyun.com
Study Locations
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Anhui
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Bengbu, Anhui, China
- Recruiting
- First Affiliated Hospital Bengbu Medical College
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Contact:
- Yang Geng, Master
- Phone Number: +86 15755235970
- Email: 495922402@qq.com
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Hefei, Anhui, China
- Recruiting
- The First Affiliated Hospital of Anhui Medical University
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Contact:
- Zaicheng Yu, Master
- Phone Number: +86 13705699600
- Email: 13705699600@163.com
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Contact:
- Renquan Zhang, Master
- Phone Number: +86 13505693475
- Email: zhangrenquan@live.cn
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Beijing
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Beijing, Beijing, China
- Recruiting
- Beijing Cancer Hospital
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Contact:
- Keneng Chen, M.D.
- Phone Number: +86 13501085973
- Email: chenkeneng@bjmu.edu.cn
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Contact:
- Liang Dai, M.D.
- Phone Number: +86 18610065191
- Email: dailiangsharp_26@aliyun.com
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Beijing, Beijing, China
- Recruiting
- China-Japan Friendship Hospital
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Contact:
- Deruo Liu, M.D.
- Phone Number: +86 13801186957
- Email: fenghongxiang617@126.com
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Beijing, Beijing, China
- Recruiting
- Chinese PLA General Hospital
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Contact:
- Zhipeng Ren, M.D.
- Phone Number: +86 15901297308
- Email: renzhipeng04@163.com
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Chongqing
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Chongqing, Chongqing, China
- Recruiting
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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Contact:
- Wei Guo, M.D.
- Phone Number: +86 13527323568
- Email: gyguowei@hotmail.com
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Fujian
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Fuzhou, Fujian, China
- Recruiting
- Union Hospital of Fujian Medical University
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Contact:
- Chun Chen, M.D.
- Phone Number: +86 13365910325
- Email: chenchun0209@163.com
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Guangdong
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Guangdong, Guangdong, China
- Recruiting
- Sun Yat-sen University Cancer Hospital
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Contact:
- Wenfeng Ye, M.D.
- Phone Number: +86 13902266462
- Email: gzyewf@hotmai.com
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Guangzhou, Guangdong, China
- Recruiting
- Guangzhou General Hospital of Guangzhou Military Command
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Contact:
- Guibin Qiao, M.D.
- Phone Number: +86 13602749153
- Email: guibinqiao@126.com
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Hebei
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Shijiazhuang, Hebei, China
- Recruiting
- Hebei Medical University Fourth Hospital
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Contact:
- Ming He, M.D.
- Phone Number: +86 13833187902
- Email: heming6699@sina.com
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Heilongjiang
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Harbin, Heilongjiang, China
- Recruiting
- The Third Affiliated Hospital of Harbin Medical University
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Contact:
- Jianqun Ma, M.D.
- Phone Number: +86 13359990466
- Email: jianqunma@aliyun.com
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Henan
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Anyang, Henan, China
- Recruiting
- Anyang Tumor Hospital
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Contact:
- Xiaotian Shi, M.D.
- Phone Number: +86 13703725817
- Email: shxt531216sh@163.com
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Hubei
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Wuhan, Hubei, China
- Recruiting
- Tongji Hospital
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Contact:
- Xiangning Fu, M.D.
- Phone Number: +86 13607150390
- Email: fuxn2006@aliyun.com
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Hunan
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Changsha, Hunan, China
- Recruiting
- Second Xiangya Hospital of Central South University
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Contact:
- Wenliang Liu, M.D.
- Phone Number: +86 13507438708
- Email: liuwenliang1859@163.com
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Jilin
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Changchun, Jilin, China
- Recruiting
- First Hospital of Jilin University
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Contact:
- Youbin Cui, M.D.
- Phone Number: +86 13364513508
- Email: cuiyb@jlu.edu.cn
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Liaoning
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Shenyang, Liaoning, China
- Recruiting
- Liaoning Tumor Hospital & Institute
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Contact:
- Hongxu Liu, M.D.
- Phone Number: +86 13840004476
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Shandong
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Jinan, Shandong, China
- Recruiting
- Qilu Hospital of Shandong University
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Contact:
- Hui Tian, M.D.
- Phone Number: +86 13791122838
- Email: tianhuiql@126.com
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Jinan, Shandong, China
- Recruiting
- Shandong Provincial Hospital
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Contact:
- Zhou Wang, M.D.
- Phone Number: +86 13665312567
- Email: wz620226@hotmail.com
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Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Shanghai Chest Hospital
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Contact:
- Zhigang Li, M.D.
- Phone Number: +86 13816121518
- Email: dr_lizhigang@hotmail.com
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Shanghai, Shanghai, China
- Recruiting
- Fudan University Cancer Hospital
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Contact:
- Hong Hu, Master
- Phone Number: +86 13512102066
- Email: huhong0997@163.com
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Shanxi
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Taiyuan, Shanxi, China
- Recruiting
- Shanxi Province Cancer Hospital
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Contact:
- Shiping Guo, Master
- Phone Number: +86 13700541808
- Email: chunhua527@126.com
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Yunan
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Kunming, Yunan, China
- Recruiting
- First People's Hospital of Yunan province
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Contact:
- Liang Bu, M.D.
- Phone Number: +86 13611000133
- Email: thoracicsurgeon@vip.sina.com
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Zhejiang
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Hanzhou, Zhejiang, China
- Recruiting
- Zhejiang Cancer Hospital
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Contact:
- Qixun Chen, M.D>
- Phone Number: +86 13958108371
- Email: chenqixun64@sina.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age below 80 years old;
- Esophageal cancer;
- Radical surgery;
- Normal gastrointestinal function
Exclusion Criteria:
- Patients with diabetes and poor blood glucose control;
- Patients with severe postoperative complications;
- Patients who can't tolerate lactose;
- Patients who decline inclusion and follow-ups
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Oral natural diet
As for patients in oral natural diet group, the the participants shall receive oral natural diet.
|
|
Oral nutrition supplement group
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 oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
|
Tube feeding nutrition supplement group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of 5% body weight loss on Day 30
Time Frame: Day 30 after discharge
|
Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
|
Day 30 after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion ratio of different nutrition support approaches
Time Frame: Day 30 after discharge
|
Completion ratio of different nutrition support approaches
|
Day 30 after discharge
|
Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale
Time Frame: Day30 and Day 90
|
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
|
Day30 and Day 90
|
Complications of home enteral nutrition support
Time Frame: Day30
|
Assessment on complications of home enteral nutrition support
|
Day30
|
Delay and interruption ratio of adjuvant treatment
Time Frame: Day 30 and Day 90
|
Delay and interruption ratio of adjuvant treatment including whether chemotherapy and radiotherapy can be implemented on time
|
Day 30 and Day 90
|
Re-hospitalization ratio
Time Frame: Day 90
|
Re-hospitalization ratio within 90 days after discharge
|
Day 90
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Keneng Chen, M.D., Peking University Cancer Hospital & Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-06-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Esophageal Cancer
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
-
National Cancer Institute (NCI)NRG OncologyCompletedEsophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IB Esophageal Cancer AJCC v7United States
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