Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
1 other identifier
observational
600
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Shorter than P25 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJanuary 23, 2018
January 1, 2018
12 months
September 15, 2017
January 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of 5% body weight loss on Day 30
Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
Day 30 after discharge
Secondary Outcomes (5)
Completion ratio of different nutrition support approaches
Day 30 after discharge
Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale
Day30 and Day 90
Complications of home enteral nutrition support
Day30
Delay and interruption ratio of adjuvant treatment
Day 30 and Day 90
Re-hospitalization ratio
Day 90
Study Arms (3)
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.
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.
Interventions
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 nutrition supplement providing 750-1500kcal/d.
Eligibility Criteria
Patients with esophageal cancer who undergo surgery
You may qualify if:
- Age below 80 years old;
- Esophageal cancer;
- Radical surgery;
- Normal gastrointestinal function
You may not qualify if:
- Patients with diabetes and poor blood glucose control;
- Patients with severe postoperative complications;
- Patients who can't tolerate lactose;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University Cancer Hospital & Institutelead
- Sun Yat-sen Universitycollaborator
- Zhejiang Cancer Hospitalcollaborator
- Shanghai Chest Hospitalcollaborator
- China-Japan Friendship Hospitalcollaborator
- Fudan Universitycollaborator
- Shandong Provincial Hospitalcollaborator
- Hebei Medical University Fourth Hospitalcollaborator
- Anyang Tumor Hospitalcollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
- The First Affiliated Hospital of Bengbu Medical Universitycollaborator
- Tongji Hospitalcollaborator
- Shanxi Province Cancer Hospitalcollaborator
- The Third Affiliated Hospital of Harbin Medical Universitycollaborator
- Liaoning Cancer Hospital & Institutecollaborator
- Wuhan General Hospital of Guangzhou Military Commandcollaborator
- Second Xiangya Hospital of Central South Universitycollaborator
- The First Hospital of Jilin Universitycollaborator
- Chinese PLA General Hospitalcollaborator
- Hunan Provincial People's Hospitalcollaborator
- Fujian Cancer Hospitalcollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Union hospital of Fujian Medical Universitycollaborator
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical Universitycollaborator
Study Sites (23)
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, China
Union hospital of Fujian Medical University
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Hospital
Guangdong, Guangdong, China
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
The Third Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Anyang Tumor Hospital
Anyang, Henan, China
Tongji Hospital
Wuhan, Hubei, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
First People's Hospital of Yunan province
Kunming, Yunan, China
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keneng Chen, M.D.
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 19, 2017
Study Start
September 20, 2017
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
January 23, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share