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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03286920
• Other study ID #: 2017-06-01
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2017
• Last updated: January 19, 2018
• Start date: September 20, 2017
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: Beijing Cancer Hospital
• Contact: Keneng Chen, M.D.
• Phone: +86 13501085973
• Email: chenkeneng[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Dietary Supplement:
• 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
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.

Locations

Country	Name	City	State
China	Anyang Tumor Hospital	Anyang	Henan
China	Beijing Cancer Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	First Affiliated Hospital Bengbu Medical College	Bengbu	Anhui
China	First Hospital of Jilin University	Changchun	Jilin
China	Second Xiangya Hospital of Central South University	Changsha	Hunan
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	Guangzhou General Hospital of Guangzhou Military Command	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hanzhou	Zhejiang
China	The Third Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	First People's Hospital of Yunan province	Kunming	Yunan
China	Fudan University Cancer Hospital	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Liaoning Tumor Hospital & Institute	Shenyang	Liaoning
China	Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei
China	Shanxi Province Cancer Hospital	Taiyuan	Shanxi
China	Tongji Hospital	Wuhan	Hubei

Sponsors (24)

Lead Sponsor

Collaborator

Beijing Cancer Hospital

Anyang Tumor Hospital, China-Japan Friendship Hospital, Chinese PLA General Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Affiliated Hospital Bengbu Medical College, First Hospital of Jilin University, Fudan University, Fujian Cancer Hospital, Hebei Medical University Fourth Hospital, Hunan Provincial People's Hospital, Liaoning Tumor Hospital & Institute, Qilu Hospital of Shandong University, Second Xiangya Hospital of Central South University, Shandong Provincial Hospital, Shanghai Chest Hospital, Shanxi Province Cancer Hospital, Sun Yat-sen University, The First Affiliated Hospital of Anhui Medical University, The Third Affiliated Hospital of Harbin Medical University, Tongji Hospital, Union hospital of Fujian Medical University, Wuhan General Hospital of Guangzhou Military Command, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Completion ratio of different nutrition support approaches	Completion ratio of different nutrition support approaches	Day 30 after discharge
Secondary	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
Secondary	Complications of home enteral nutrition support	Assessment on complications of home enteral nutrition support	Day30
Secondary	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
Secondary	Re-hospitalization ratio	Re-hospitalization ratio within 90 days after discharge	Day 90