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CompletedNCT00828399Updated May 25, 2011

Prevention of Acute Radiation Enteritis With Glutamine

A Phase 4 interventional study of Glutamine and Whole protein in Acute Radiation Enteritis, sponsored by Castilla-León Health Service. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-25.

Sponsored by Castilla-León Health Service · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Acute Radiation Enteritis

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Keywords

  • Radiotherapy
  • Diarrhoea
  • Glutamine
  • Oxydative stress
  • Calprotectin
  • Citrulline
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In context

Diarrhea

877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.

This study's enrollment of 70 is below the median of 137 across 738 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Castilla-León Health Service is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \< 1 yr
  • Age \< 18 yr
  • gut diseases: inflammatory bowel disease,sprue, irritable bowel disease...
  • moderate to severe chronic renal failure
  • hepatic cirrhosis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Glutamine

    Dietary Supplement: Glutamine

  • Placebo comparator
    Whole protein

    Dietary Supplement: Whole protein

Interventions

  • Dietary supplementGlutamine

    Oral glutamine 30g/day

  • Dietary supplementWhole protein

    Oral whole protein 30 g/day

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What researchers measure

Primary outcomes

  1. Number of patients with acute radiation enteritis

    RTOG criteria

    Time frame: 2 months

Secondary outcomes

  1. Reduction in inflammatory markers and oxydative stress

    Time frame: 2 months

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Study locations

1 site
  • Complejo Asistencial de León.
    Leon, 24008, Spain
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References and documents

Publications

  • Kozelsky TF, Meyers GE, Sloan JA, Shanahan TG, Dick SJ, Moore RL, Engeler GP, Frank AR, McKone TK, Urias RE, Pilepich MV, Novotny PJ, Martenson JA; North Central Cancer Treatment Group. Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. J Clin Oncol. 2003 May 1;21(9):1669-74. doi: 10.1200/JCO.2003.05.060. PubMed 12721240 ↗
  • Giris M, Erbil Y, Oztezcan S, Olgac V, Barbaros U, Deveci U, Kirgiz B, Uysal M, Toker GA. The effect of heme oxygenase-1 induction by glutamine on radiation-induced intestinal damage: the effect of heme oxygenase-1 on radiation enteritis. Am J Surg. 2006 Apr;191(4):503-9. doi: 10.1016/j.amjsurg.2005.11.004. PubMed 16531144 ↗
  • Ersin S, Tuncyurek P, Esassolak M, Alkanat M, Buke C, Yilmaz M, Telefoncu A, Kose T. The prophylactic and therapeutic effects of glutamine- and arginine-enriched diets on radiation-induced enteritis in rats. J Surg Res. 2000 Apr;89(2):121-5. doi: 10.1006/jsre.1999.5808. PubMed 10729239 ↗
  • de Urbina JJ, Jorquera F, Culebras JM, Villares C, Gonzalez-Gallego J, Tunon MJ. Effects of parenteral nutrition supplemented with alanyl-glutamine on nutrition status in rats. JPEN J Parenter Enteral Nutr. 2005 Jul-Aug;29(4):262-5. doi: 10.1177/0148607105029004262. PubMed 15961682 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00828399
Lead sponsor
Castilla-León Health Service
First posted
Jan 23, 2009
Start date
Jan 2009
Primary completion
May 2011
Completion
May 2011
Last update
May 25, 2011

Study contacts

Alfonso Vidal Casariego, MD
principal investigator · Sección de Endocrinología y Nutrición. Complejo Asistencial de León

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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