Prevention of Acute Radiation Enteritis With Glutamine

May 24, 2011 updated by: Castilla-León Health Service

Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.

Ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. A common adverse effect of radiation is acute diarrhoea. Glutamine is an aminoacid with antioxidant effects that can protect tissues of damage dued to radiation. The investigators designed a randomized, double-blind trial phase III to study if glutamine prevents acute radiation enteritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

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

  • Spain
      • Leon, Spain, 24008
        • Complejo Asistencial de León.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 yr
  • Gynaecological,prostatic, rectal or other abdominal cancer
  • Radiotherapy with/without chemotherapy

Exclusion Criteria:

  • life expectancy < 1 yr
  • Age < 18 yr
  • gut diseases: inflammatory bowel disease,sprue, irritable bowel disease...
  • moderate to severe chronic renal failure
  • hepatic cirrhosis

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glutamine
Dietary supplement: Glutamine
Oral glutamine 30g/day
Placebo Comparator: Whole protein
Dietary supplement: Whole protein
Oral whole protein 30 g/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with acute radiation enteritis
Time Frame: 2 months
RTOG criteria
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in inflammatory markers and oxydative stress
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

Castilla-León Health Service

Investigators

  • Principal Investigator: Alfonso Vidal Casariego, MD, Sección de Endocrinología y Nutrición. Complejo Asistencial de León

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

January 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Estimate)

May 25, 2011

Last Update Submitted That Met QC Criteria

May 24, 2011

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-2008-BecaSacyl

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.

Clinical Trials on Acute Radiation Enteritis

Clinical Trials on Glutamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe