Biological Assessment of Clinical Nutrition and Its Application

Not Applicable

• Conditions: Malnutrition
• Interventions: Genetic: Upper Limit Nutrition Support Therapy; Genetic: Formula Nutrition Support Therapy

• Registration Number: NCT02102659
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

1. Clinical nutritional support therapy is an important progress of modern medicine.

2. Conventional methods of clinical nutrition assessment (Anthropometric, lab, etc.) not just lack of accuracy and immediacy but also difficult to dynamically reflect the fluctuation trend of nutrition status.

3. It has been reported that malnutrition affects proliferation and apoptosis of human cells in vivo. This preliminary study was initiated by the hypothesis that changes in nutritional status may be reflected rapidly in fast proliferating cells.

4. In the previous studies the investigators already found that apoptosis rate of oral mucosal epithelium could reflect changes in nutritional status.There were an obvious decreasing in apoptosis and proliferation rate of oral mucosal epithelium in malnourished patients.

5. Based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau being achieved by increase the nutrition amount continuously, Maintain this amount of nutrition given until the end of treatment. The investigators call this amount of nutrition the "upper limit nutrition support therapy".

6. The patients applying for"upper limit nutrition support therapy" and "Formula nutrition support therapy" separately, comparing of the two methods influences on postoperative wound healing, postoperative complication rate ,inflammatory response, side effects of chemotherapy, hospital stays and hospitalization expenses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-27
• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted QC: 2014-04-02
• Last Update Submitted: 2014-04-02
• Study First Posted: 2014-04-03
• Last Update Posted: 2014-04-03
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

1. Patients with Gastric cancer or colorectal cancer which confirmed by Preoperative pathology will be included.
2. Patients who are diagnosed as malnutrition according history, physical examination and Nutrition Risk Screening 2002 will be included.
3. patients who have digestive tract fistula because of operation complication will be included.
4. patients who need fast track recovery after colorectal cancer operation will be included.

Exclusion Criteria

1. Patients who are diagnosed as Late stage (stage IV) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded.
2. Postoperative gastric cancer or colorectal cancer patients who is Unable to tolerate the chemotherapy or unable to complete the whole chemotherapy course will be excluded.
3. patients with Severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded.
4. patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper Limit Nutrition Support Therapy	Upper Limit Nutrition Support Therapy	"Upper limit nutrition support therapy" will be used in patens assigned to this group based on the patient's curve of apoptosis of oral mucosal epithelium.
Formula Nutrition Support Therapy	Formula Nutrition Support Therapy	"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.

Primary Outcome Measures

Name	Time	Method
The Length and Width of Surgical Incision Edema	9th day	The length and width of surgical incision edema will be measured by doppler ultrasonography in the 9th day respectively after gastrointestinal operation.

Secondary Outcome Measures

Name	Time	Method
Oral Mucosal Epithelial Cell Apoptosis Rate	10 or 12 days	Oral mucosal epithelial cell samples will be collected in the every morning before tooth brushing teeth for 9 days after gastrointestinal operation..The cells well be analyzed by flow cytometry for detecting apoptosis rate.
The level of serum proteins	9 days	The serum proteins including retinol-binding protein (RBP), transferrin, prealbumin (PA), and albumin will be measured every 2-3 days for 9 days after gastrointestinal operation.
Anthropometric measurements	9 days	Anthropometric measurements including weight, body mass index, triceps skinfold thickness, and midarm muscle circumference will be recorded every 2-3 days days for 9 days after gastrointestinal operation..

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China