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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Shanghai Chest Hospital | OTHER |
| China-Japan Friendship Hospital |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral nutrition supplement | Dietary 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with esophageal cancer who undergo surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keneng Chen, M.D. | Contact | +86 13501085973 | chenkeneng@bjmu.edu.cn | |
| Liang Dai, M.D. | Contact | +86 18610065191 | dailiangsharp_26@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Keneng Chen, M.D. | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital Bengbu Medical College | Recruiting | Bengbu | Anhui | China |
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| OTHER |
| Fudan University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Hebei Medical University Fourth Hospital | OTHER |
| Anyang Tumor Hospital | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
| Tongji Hospital | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| The Third Affiliated Hospital of Harbin Medical University | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| Wuhan General Hospital of Guangzhou Military Command | OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
| The First Hospital of Jilin University | OTHER |
| Chinese PLA General Hospital | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Qilu Hospital of Shandong University | OTHER |
| Union hospital of Fujian Medical University | OTHER |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | OTHER |
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| Tube feeding nutrition supplement | Dietary 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. |
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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 |
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
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| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
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| Union hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
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| Sun Yat-sen University Cancer Hospital | Recruiting | Guangdong | Guangdong | China |
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| Guangzhou General Hospital of Guangzhou Military Command | Recruiting | Guangzhou | Guangdong | China |
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| Hebei Medical University Fourth Hospital | Recruiting | Shijiazhuang | Hebei | China |
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| The Third Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | China |
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| Anyang Tumor Hospital | Recruiting | Anyang | Henan | China |
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| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
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| Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| First Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| Liaoning Tumor Hospital & Institute | Recruiting | Shenyang | Liaoning | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | China |
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| Fudan University Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shanxi Province Cancer Hospital | Recruiting | Taiyuan | Shanxi | China |
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| First People's Hospital of Yunan province | Recruiting | Kunming | Yunan | China |
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| Zhejiang Cancer Hospital | Recruiting | Hanzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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