Prevention of Acute Radiation Enteritis With Glutamine

This study has been completed.
Sponsor:
Information provided by:
Castilla-León Health Service
ClinicalTrials.gov Identifier:
NCT00828399
First received: January 22, 2009
Last updated: May 24, 2011
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Acute Radiation Enteritis
Dietary Supplement: Glutamine
Dietary Supplement: Whole protein
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.

Resource links provided by NLM:


Further study details as provided by Castilla-León Health Service:

Primary Outcome Measures:
  • Number of patients with acute radiation enteritis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    RTOG criteria


Secondary Outcome Measures:
  • Reduction in inflammatory markers and oxydative stress [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glutamine Dietary Supplement: Glutamine
Oral glutamine 30g/day
Placebo Comparator: Whole protein Dietary Supplement: Whole protein
Oral whole protein 30 g/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828399

Locations
Spain
Complejo Asistencial de León.
Leon, Spain, 24008
Sponsors and Collaborators
Castilla-León Health Service
Investigators
Principal Investigator: Alfonso Vidal Casariego, MD Sección de Endocrinología y Nutrición. Complejo Asistencial de León
  More Information

Publications:
Responsible Party: MD Alfonso Vidal Casariego, Complejo Asistencial de Leóm
ClinicalTrials.gov Identifier: NCT00828399     History of Changes
Other Study ID Numbers: 001-2008-BecaSacyl
Study First Received: January 22, 2009
Last Updated: May 24, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Castilla-León Health Service:
Radiotherapy
Diarrhoea
Glutamine
Oxydative stress
Calprotectin
Citrulline

Additional relevant MeSH terms:
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 20, 2014