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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014