Overview

This trial is active, not recruiting.

Condition malnutrition
Treatments upper limit nutrition support therapy, formula nutrition support therapy
Sponsor Huazhong University of Science and Technology
Start date March 2014
End date November 2015
Trial size 167 participants
Trial identifier NCT02102659, TJ-20130803

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
"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.
upper limit nutrition support therapy Apoptosis rate of human oral epithelial cells
"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
(Active Comparator)
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.
formula nutrition support therapy
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.

Primary Outcomes

Measure
The Length and Width of Surgical Incision Edema
time frame: 2nd day
The Length and Width of Surgical Incision Edema
time frame: 9th day

Secondary Outcomes

Measure
Oral Mucosal Epithelial Cell Apoptosis Rate
time frame: 10 or 12 days
Anthropometric measurements
time frame: 9 days
The level of serum proteins
time frame: 9 days

Eligibility Criteria

Male or female participants from 16 years up to 80 years old.

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.

Additional Information

Official title This Preliminary Study Was Designed to Explore a New Biological Method for Nutritional Assessment by Measuring Oral Mucosal Epithelial Cell Apoptosis Rate and Guideline to Clinical Nutrition Support Therapy for Improving Clinical Outcome of Malnourished Patients.
Principal investigator Jianping Gong, M.D.,Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Huazhong University of Science and Technology.