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OpenTrials
Completed

NCT Number: NCT00828399

Prevention of Acute Radiation Enteritis With Glutamine

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.

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Key information

Conditions

Acute Radiation Enteritis Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Complejo Asistencial de León.

León, Leon, 24008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutamine

Dietary Supplement

Oral glutamine 30g/day

Whole protein

Dietary Supplement

Oral whole protein 30 g/day

Primary outcomes

  1. Number of patients with acute radiation enteritis

    Time frame: 2 months

    RTOG criteria

Secondary outcomes

  1. Reduction in inflammatory markers and oxydative stress

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Castilla-León Health Service

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 23, 2009
Registry last updated
May 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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