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Therapy of Radiation Enteritis With Glutamine

Sponsor
Nanjing University School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT01758783
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
13
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral nutrition support on nutritional status, immunologic function and intestinal permeability of patients with chronic radiation intestinal injury.

Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group and glutamine-enriched TPN group. The patients were administered total parenteral nutrition for at least four weeks (two weeks pre-operation and two weeks post-operation). The nutritional status, immunologic function, plasma concentration of glutamine and intestinal permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2 weeks post-operation. Nutrition status was determined the plasma concentrations of hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to CD8+T cells ( CD4 +/CD8 +) was calculated， and serum IgA, IgM and IgG．The intestinal permeability was detected by the urinal ratio of lactulose and mannitol.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
Study Start Date :
Jun 1, 2012
Anticipated Primary Completion Date :
Jun 1, 2013
Anticipated Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo group

Drug: Glutamine
amino acid：1.2-2g/(kg·d) Glutamine：0.5g /(kg·d)
Experimental: Glutamine group

Drug: Glutamine
amino acid：1.2-2g/(kg·d) Glutamine：0.5g /(kg·d)

Outcome Measures

Primary Outcome Measures

  1. inflammatory factor [2 weeks after the surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Clinical diagnosis of chronic radiation enteritis

  • Need the operation

  • Malnutrition

Exclusion Criteria:

  • Hepatic failure

  • Kidney failure

  • Neoplasm recurrence

  • Serious cardiovascular/metabolic disease

  • Pregnancy and lactation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Surgery, Nanjing General Hospital of Nanjing Command Nanjing Jiangsu China 210002

Sponsors and Collaborators

  • Nanjing University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Zheng, Resident, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01758783
Other Study ID Numbers:
  • Radiation Enteritis 001
First Posted:
Jan 1, 2013
Last Update Posted:
Jan 4, 2013
Last Verified:
Jan 1, 2013
Additional relevant MeSH terms:
Enteritis

Study Results

No Results Posted as of Jan 4, 2013