A Phase 2 interventional study of Glutamine and Placebo in Kidney Cancer, Leukemia and Lymphoma, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2016-09-09.
Sponsored by Columbia University · Phase 2, Interventional, and Supportive care
RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine.
PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.
Patients in both arms undergo neuropsychological and clinical neurological assessment, blood collection for serum marker (e.g., serum glutamine and nerve growth factor) analysis, and quality of life assessment on days 1, 21, and 42.
After completion of study treatment, patients are followed for an additional 21 days.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 56 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
Drug: Glutamine
Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
Other: Placebo
Administered orally twice daily for 21 days
Also known as: Nutritional Supplement
Administered orally twice daily for 21 days
Incidence of Vincristine-induced Peripheral Neuropathy
Time frame: Up to 30 weeks from baseline while on Vincristine treatment
Number of Participants With Progression of Neuropathy
Time frame: 42 days
All subjects were consented according to Institutional Review Board approved guidelines during out routine outpatient or inpatient stay. The period of recruitment was from January 2007 to July 2011.
| Milestone | Arm I: Glutamine | Arm II: Placebo |
|---|---|---|
| Started | 24 | 25 |
| Completed | 24 | 25 |
| Not completed | 0 | 0 |
| participants | Arm I: Glutamine | Arm II: Placebo |
|---|---|---|
| Incidence of Vincristine-induced Peripheral Neuropathy | 24 | 25 |
| participants | Arm I: Glutamine | Arm II: Placebo |
|---|---|---|
| Number of Participants With Progression of Neuropathy | 11 | 19 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I: Glutamine | — | 0/24 (0%) | 0/24 (0%) |
| Arm II | — | 0/25 (0%) | 0/25 (0%) |
Fifty-six patients were enrolled and 49 were evaluable.
| Age, Continuous(years) | Arm I: Glutamine | Arm II: Placebo | Total |
|---|---|---|---|
| Median | 11 (5 to 19) | 10 (4 to 17) | 11 (4 to 19) |
| Sex: Female, Male(Participants) | Arm I: Glutamine | Arm II: Placebo | Total |
|---|---|---|---|
| Female | 14 | 12 | 26 |
| Male | 10 | 13 | 23 |
| Region of Enrollment(participants) | Arm I: Glutamine | Arm II: Placebo | Total |
|---|---|---|---|
| United States | 24 | 25 | 49 |
Plan to share: Undecided
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