Oral ComplicationsPhase 2NCT00003898
Glutamine in Treating Side Effects in Children Who Are Undergoing Stem Cell Transplantation
A Phase 2 study testing glutamine in people with Oral Complications and Unspecified Childhood Solid Tumor, Protocol Specific, run by Roswell Park Cancer Institute at 2 sites in United States.
Trial summary
RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system in children who are undergoing stem cell transplantation. PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in reducing inflammation of the mouth and digestive system in children who are… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Oral Complications, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- glutamine
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 1999to Jan 2004
- Phase
- Phase 2
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Undergoing allogeneic or autologous stem cell transplant (including bone marrow, cord blood, or peripheral blood stem cells) Conditioning regimen must have at least 50% risk of grade III or IV mucositis No grade III or IV hepatic toxicity
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not specified Other: No grade III or IV toxicity at admission for stem cell transplant No altered mental status
PRIOR CONCURRENT THERAPY: No concurrent vancomycin paste or nonabsorbable antibiotics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
About this study
Official title: The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study
RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system in children who are undergoing stem cell transplantation.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in reducing inflammation of the mouth and digestive system in children who are undergoing peripheral stem cell transplantation.
Read the detailed description
OBJECTIVES: I. Determine the efficacy of supplemental oral glutamine in reducing the severity and duration of mucositis in children undergoing stem cell transplantation. II. Determine the safety of this regimen in these patients. III. Determine serum glutamine levels achieved during this regimen in these patients.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to inclusion of total body irradiation in the conditioning regimen (yes vs no). Patients receive either oral glutamine or oral placebo (glycine) twice a day beginning on the day of admission for the stem cell transplant and continuing for 28 days or until hospital discharge, whichever is first.
PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study within 2 years.
- Being tested
- glutamine
- Keywords
- unspecified childhood solid tumor, protocol specific, oral complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutamineDietary supplement
Oral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2004 (estimated)
- Study startJan 1999
- Primary completionJun 2003
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral ComplicationsStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Barbara Jean Bambach, MD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003898
- Sponsor's protocol ID
- CDR0000067069
- Other IDs
- RPCI-RP-9810
- Status last verified
- Feb 2011
- First submitted
- 1 Nov 1999
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aquino VM, Harvey A, Garvin J, et al.: The use of supplemental glutamine to decrease morbidity in children undergoing stem cell transplantation: a Pediatric Blood and Marrow Transplant Consortium study. [Abstract] 2004 Pediatric Academic Societies' Annual Meeting, May 1-4, San Francisco, California. A-1627, 2004. Availabel online Last accessed August 29, 2005.
Aquino VM, Harvey AR, Garvin JH, Godder KT, Nieder ML, Adams RH, Jackson GB, Sandler ES. A double-blind randomized placebo-controlled study of oral glutamine in the prevention of mucositis in children undergoing hematopoietic stem cell transplantation: a pediatric blood and marrow transplant consortium study. Bone Marrow Transplant. 2005 Oct;36(7):611-6. doi: 10.1038/sj.bmt.1705084.
PubMed 16086046
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study
- ClinicalTrials.gov ID
- NCT00003898
- Acronym / sponsor ID
- CDR0000067069
- Keywords
- unspecified childhood solid tumor, protocol specific, oral complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 17 Jun 2004 (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.
RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system in children who are undergoing stem cell transplantation.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in reducing inflammation of the mouth and digestive system in children who are undergoing peripheral stem cell transplantation.
Detailed description
OBJECTIVES: I. Determine the efficacy of supplemental oral glutamine in reducing the severity and duration of mucositis in children undergoing stem cell transplantation. II. Determine the safety of this regimen in these patients. III. Determine serum glutamine levels achieved during this regimen in these patients.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to inclusion of total body irradiation in the conditioning regimen (yes vs no). Patients receive either oral glutamine or oral placebo (glycine) twice a day beginning on the day of admission for the stem cell transplant and continuing for 28 days or until hospital discharge, whichever is first.
PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 | Dietary supplement | – |
Primary outcome
Not reported in the source record.
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 1 Mar 2011.
- Results publicationAquino VM, Harvey A, Garvin J, et al.: The use of supplemental glutamine to decrease morbidity in children undergoing stem cell transplantation: a Pediatric Blood and Marrow Transplant Consortium study. [Abstract] 2004 Pediatric Academic Societies' Annual Meeting, May 1-4, San Francisco, California. A-1627, 2004. Availabel online Last accessed August 29, 2005.
- Results publication: PubMed 16086046Aquino VM, Harvey AR, Garvin JH, Godder KT, Nieder ML, Adams RH, Jackson GB, Sandler ES. A double-blind randomized placebo-controlled study of oral glutamine in the prevention of mucositis in children undergoing hematopoietic stem cell transplantation: a pediatric blood and marrow transplant consortium study. Bone Marrow Transplant. 2005 Oct;36(7):611-6. doi: 10.1038/sj.bmt.1705084.
Related trials for Oral Complications
Not yet recruiting
Effects of Irrigation Solutions at Different Temperatures Used in Mandibular Third Molar Surgery
Third Molars Extraction, Oral Health-Related Quality of Life
Not yet recruitingObservational study
The Effect of the Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube From the Pylorus on Postoperative Outcomes
Poor Oral Intake, Percutaneous Endoscopic Gastrostomy
Active, not recruiting
Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study
Oral Bacterial Infection, Mechanical Ventilation Complication
Not yet recruiting
Evaluating The Use of CGF Made Gel in Mandibular Extraction Sites of Lower Impacted 3rd Molars.
Impacted Lower Third Molar, Alveolar Bone Regeneration Following Odontectomy
Not yet recruiting
Evaluating The Use of CGF Made Plugs in Mandibular Extraction Sites of Lower Impacted 3rd Molars.
Impacted Lower Third Molar, Alveolar Bone Regeneration Following Odontectomy
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.
Barbara Jean Bambach, MD study chair
Roswell Park Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glutamine in people with Oral Complications and Unspecified Childhood Solid Tumor, Protocol Specific, run by Roswell Park Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003898, which also lists 2 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 1 Mar 2011; AzTrials last refreshed its copy on 6 Nov 2026.