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NCT00365768 · REGISTRY CONDITION SEARCH

Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2016-09-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Incidence of Vincristine-induced Peripheral Neuropathy

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outcome · POSTED

Number of Participants With Progression of Neuropathy

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients between the age of 5 and 21 years old. * Patients who demonstrate the ability to complete the assessment instruments at baseline. * Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of \> or = to 6mg/m2 of vincristine, or \> 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period. Exclusion Criteria: * Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis. * Patients with recurrent disease. * Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam. * Patients who have already received \> 8mg/m2 of vincristine, or \> 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent. * Patients with hepatic encephalopathy or hyperammonemia. * Patients with a focally abnormal neurologic exam.
healthy Volunteers
false
maximum Age
21 Years
minimum Age
5 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
    intervention Names
    1. Drug: Glutamine
    label
    Arm I: Glutamine
    type
    EXPERIMENTAL
  2. description
    Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
    intervention Names
    1. Other: Placebo
    label
    Arm II: Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I: Glutamine
    description
    Administered orally twice daily for 21 days
    name
    Glutamine
    other Names
    1. Nutritional Supplement
    type
    DRUG
  2. arm Group Labels
    1. Arm II: Placebo
    description
    Administered orally twice daily for 21 days
    name
    Placebo
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
56
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Incidence of Vincristine-induced Peripheral Neuropathy
    time Frame
    Up to 30 weeks from baseline while on Vincristine treatment
secondary Outcomes
  1. measure
    Number of Participants With Progression of Neuropathy
    time Frame
    42 days
Full study description
brief Summary
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.
detailed Description
OBJECTIVES: Primary * Determine the incidence of vincristine-induced peripheral neuropathy in pediatric patients with lymphoma, leukemia, or solid tumors. Secondary * Compare the safety of glutamine vs placebo in these patients. * Compare the efficacy of glutamine vs placebo in reducing the progression and/or resolution of vincristine-induced peripheral neuropathy in these patients. * Compare the effect of glutamine supplementation vs placebo on chemotherapy-related toxicities in these patients. * Compare the effect of glutamine vs placebo on measures of quality of life in these patients. * Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor and glutamine levels in these patients. * Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro. OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21. * Arm II: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21. 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.
Source references
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice