Biological Assessment of Clinical Nutrition and Its Application

April 2, 2014 updated by: Jianping Gong, Huazhong University of Science and Technology

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.

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Genetic: 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
Other Names:
  • Apoptosis rate of human oral epithelial cells
Active Comparator: Formula Nutrition Support Therapy
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.
Genetic: Formula Nutrition Support Therapy
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Length and Width of Surgical Incision Edema
Time Frame: 2nd day
The length and width of surgical incision edema will be measured by doppler ultrasonography in the 2nd day respectively after gastrointestinal operation.
2nd day
The Length and Width of Surgical Incision Edema
Time Frame: 9th day
The length and width of surgical incision edema will be measured by doppler ultrasonography in the 9th day respectively after gastrointestinal operation.
9th day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Mucosal Epithelial Cell Apoptosis Rate
Time Frame: 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.
10 or 12 days
Anthropometric measurements
Time Frame: 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..
9 days
The level of serum proteins
Time Frame: 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.
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Estimate)

April 3, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-20130803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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