Acute Radiation EnteritisPhase 4NCT00828399
Prevention of Acute Radiation Enteritis With Glutamine
A Phase 4 study testing Glutamine and Whole protein in people with Acute Radiation Enteritis, run by Castilla-León Health Service at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Radiation Enteritis
- What is being tested?
- Glutamine and Whole protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 yr
- Gynaecological,prostatic, rectal or other abdominal cancer
- Radiotherapy with/without chemotherapy
Who cannot join
- life expectancy < 1 yr
- Age < 18 yr
- gut diseases: inflammatory bowel disease,sprue, irritable bowel disease...
- moderate to severe chronic renal failure
- hepatic cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
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.
- Conditions
- Acute Radiation Enteritis
- Being tested
- Glutamine, Whole protein
- Keywords
- Radiotherapy, Diarrhoea, Glutamine, Oxydative stress, Calprotectin, Citrulline
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDietary supplement
Oral glutamine 30g/day
Whole proteinDietary supplement
Oral whole protein 30 g/day
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | Not described Receives: Dietary Supplement: Glutamine |
| Whole protein | Placebo comparator | Not described Receives: Dietary Supplement: Whole protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with acute radiation enteritis
RTOG criteria
Measured: 2 months
Secondary outcomes (1)
Reduction in inflammatory markers and oxydative stress
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Radiation EnteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castilla-León Health Service
- Sponsor type
- University, hospital or other
- Investigators
- Alfonso Vidal Casariego, MD, Principal investigator, Sección de Endocrinología y Nutrición. Complejo Asistencial de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828399
- Sponsor's protocol ID
- 001-2008-BecaSacyl
- Status last verified
- Jan 2009
- First submitted
- 22 Jan 2009
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
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 12721240Giris 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 16531144Ersin 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 10729239de 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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
- ClinicalTrials.gov ID
- NCT00828399
- Acronym / sponsor ID
- 001-2008-BecaSacyl
- Conditions
- Acute Radiation Enteritis
- Keywords
- Radiotherapy, Diarrhoea, Glutamine, Oxydative stress, Calprotectin, Citrulline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Castilla-León Health ServiceUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Dietary Supplement: Glutamine |
| Whole protein | Placebo comparator | Dietary Supplement: Whole protein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 yr
- Gynaecological,prostatic, rectal or other abdominal cancer
- Radiotherapy with/without chemotherapy
Key exclusion criteria (5 listed)
- life expectancy < 1 yr
- Age < 18 yr
- gut diseases: inflammatory bowel disease,sprue, irritable bowel disease...
- moderate to severe chronic renal failure
- hepatic cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutamineOral glutamine 30g/day | Dietary supplement | Glutamine |
| Whole proteinOral whole protein 30 g/day | Dietary supplement | Whole protein |
Primary outcome
Number of patients with acute radiation enteritis
Time frame: 2 months
RTOG criteria
1 secondary outcome
Reduction in inflammatory markers and oxydative stress
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
- Results publication: PubMed 12721240Kozelsky 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.
- Results publication: PubMed 16531144Giris 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.
- Results publication: PubMed 10729239Ersin 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.
- Results publication: PubMed 15961682de 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.
Related trials for Acute Radiation Enteritis
Not yet recruitingObservational study
Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy
Radiation Enteritis
Not yet recruitingPhase 2
Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury
Acute Radiation Enteritis
Not yet recruitingPhase 2
Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy
Acute Radiation Enteritis
Enrolling by invitationPhase 1/2
Gegen Qinlian Tang and Probiotics for Radiation Enteritis
Acute Radiation Enteritis
Not yet recruitingPhase 1/2
Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients
Radiotherapy Induced Diarrhea, Acute Radiation Enteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfonso Vidal Casariego, MD principal investigator
Sección de Endocrinología y Nutrición. Complejo Asistencial de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glutamine and Whole protein in people with Acute Radiation Enteritis, run by Castilla-León Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with acute radiation enteritis (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828399, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2011.