Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Dietary Supplement: Oral nutrition supplement
* Dietary Supplement: Tube feeding nutrition supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral natural diet<br>As for patients in oral natural diet group, the the participants shall receive oral natural diet. | |
| Oral nutrition supplement group<br>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. | Dietary Supplement: Oral nutrition supplement<br>* 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.<br>|
| Tube feeding nutrition supplement group<br>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. | Dietary Supplement: Tube feeding nutrition supplement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion ratio of different nutrition support approaches | Completion ratio of different nutrition support approaches | Day 30 after discharge | 
| Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale | 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 | Assessment on complications of home enteral nutrition support | Day30 | 
| Delay and interruption ratio of adjuvant treatment | 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 | Re-hospitalization ratio within 90 days after discharge | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home nutrition, BMI, postoperative, body weight