Acute Radiation Enteritis
Conditions
Keywords
Radiotherapy, Diarrhoea, Glutamine, Oxydative stress, Calprotectin, Citrulline
Brief 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.
Interventions
DIETARY_SUPPLEMENTGlutamine
Oral glutamine 30g/day
DIETARY_SUPPLEMENTWhole protein
Oral whole protein 30 g/day
Sponsors
Castilla-León Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with acute radiation enteritis | 2 months | RTOG criteria |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in inflammatory markers and oxydative stress | 2 months |
Countries
Spain
Outcome results
None listed