Clinical trial NCT03286920: Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
Official title: Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Keywords: home nutrition
BMI
postoperative
body weight
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Zhejiang Cancer Hospital
name: Shanghai Chest Hospital
name: China-Japan Friendship Hospital
name: Fudan University
name: Shandong Provincial Hospital
name: Hebei Medical University Fourth Hospital
name: Anyang Tumor Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: The First Affiliated Hospital of Bengbu Medical University
name: Tongji Hospital
name: Shanxi Province Cancer Hospital
name: The Third Affiliated Hospital of Harbin Medical University
name: Liaoning Cancer Hospital & Institute
name: Wuhan General Hospital of Guangzhou Military Command
name: Second Xiangya Hospital of Central South University
name: The First Hospital of Jilin University
name: Chinese PLA General Hospital
name: Hunan Provincial People's Hospital
name: Fujian Cancer Hospital
name: Qilu Hospital of Shandong University
name: Union hospital of Fujian Medical University
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
First posted: 2017-09-19
Enrollment: 600
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophageal cancer who undergo surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of 5% body weight loss on Day 30
timeFrame: Day 30 after discharge
Secondary outcomes:
measure: Completion ratio of different nutrition support approaches
timeFrame: Day 30 after discharge
measure: Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale
timeFrame: Day30 and Day 90
measure: Complications of home enteral nutrition support
timeFrame: Day30
measure: Delay and interruption ratio of adjuvant treatment
timeFrame: Day 30 and Day 90
measure: Re-hospitalization ratio
timeFrame: Day 90
Other outcomes:
Locations:
city: Bengbu
country: China
facility: First Affiliated Hospital Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Union hospital of Fujian Medical University
state: Fujian
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou General Hospital of Guangzhou Military Command
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
city: Harbin
country: China
facility: The Third Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Tumor Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: Second Xiangya Hospital of Central South University
state: Hunan
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Tumor Hospital & Institute
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
state: Shanxi
city: Kunming
country: China
facility: First People's Hospital of Yunan province
state: Yunan
city: Hanzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Keneng Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: