An observational study in Esophageal Cancer, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 23 sites in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Peking University Cancer Hospital & Institute · Observational
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.
Patients with esophageal cancer who undergo surgery
Exclusion Criteria:
As for patients in oral natural diet group, the the participants 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.
Dietary Supplement: Oral 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.
Dietary Supplement: Tube feeding 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.
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.
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
Time frame: Day 30 after discharge
Completion ratio of different nutrition support approaches
Completion ratio of different nutrition support approaches
Time frame: 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
Time frame: Day30 and Day 90
Complications of home enteral nutrition support
Assessment on complications of home enteral nutrition support
Time frame: 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
Time frame: Day 30 and Day 90
Re-hospitalization ratio
Re-hospitalization ratio within 90 days after discharge
Time frame: Day 90
Plan to share: No
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Peking University Cancer Hospital & Institute