Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Dietary Supplement: Oral nutrition supplementDietary Supplement: Tube feeding nutrition supplement
- Registration Number
- NCT03286920
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- 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.
- 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:
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- Age below 80 years old;
- Esophageal cancer;
- Radical surgery;
- Normal gastrointestinal function
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Oral nutrition supplement group Oral nutrition supplement 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 Tube feeding nutrition supplement 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.
- Primary Outcome Measures
Name Time Method Percentage of 5% body weight loss on Day 30 Day 30 after discharge Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
- Secondary Outcome Measures
Name Time Method Complications of home enteral nutrition support Day30 Assessment on complications of home enteral nutrition support
Completion ratio of different nutrition support approaches Day 30 after discharge Completion ratio of different nutrition support approaches
Delay and interruption ratio of adjuvant treatment Day 30 and Day 90 Delay and interruption ratio of adjuvant treatment including whether chemotherapy and radiotherapy can be implemented on time
Re-hospitalization ratio Day 90 Re-hospitalization ratio within 90 days after discharge
Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale 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
Trial Locations
- Locations (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, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Guangzhou General Hospital of Guangzhou Military Command
🇨🇳Guangzhou, Guangdong, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Union hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Sun Yat-sen University Cancer Hospital
🇨🇳Guangdong, 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
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China
Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
Shanxi Province Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
First People's Hospital of Yunan province
🇨🇳Kunming, Yunan, China
Zhejiang Cancer Hospital
🇨🇳Hanzhou, Zhejiang, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Liaoning Tumor Hospital & Institute
🇨🇳Shenyang, Liaoning, China
First Hospital of Jilin University
🇨🇳Changchun, Jilin, China