Sands, S., Ladas, E.J., Kelly, K.M., Weiner, M., Lin, M., Ndao, D.H., . . . Bender, J.G. (2017). Glutamine for the treatment of vincristine-induced neuropathy in children and adolescents with cancer. Supportive Care in Cancer, 25, 701–708. 

DOI Link

Study Purpose

To examine the efficacy and safety of glutamine to reduce vincristine-induced neuropathy in children and adolescents

Intervention Characteristics/Basic Study Process

Patients expected to receive a cumulative dose of 6 mg/m2 over a 30-week period were randomized to receive glutamine or placebo. Participants' families were contacted weekly to answer questions and monitor compliance and monitor adverse effects. Study medications were provided in a powder formulation to be mixed in juice for oral administration. Study measures were obtained at baseline, after 21 days, and on day 42 after a wash-out period. Glutamine was given at a dose of 6 g/m2 twice daily up to a maximum dose of 10 g.

Sample Characteristics

  • N = 49   
  • MEDIAN AGE = 11 years
  • AGE RANGE = 4–19 years
  • MALES: 48.2%, FEMALES: 51.8%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Hematologic malignancies; acute lymphoblastic leukemia was the most common.
  • OTHER KEY SAMPLE CHARACTERISTICS: More than 50% were Hispanic.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: New York

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

Double-blind, placebo-controlled, randomized, controlled trial

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
  • Purdue Pegboard test
  • Grip strength
  • Symbol Digit Modalities Test
  • Pedatric quality of life

Results

Seventy-eight percent developed peripheral neuropathy as defined by CTCAE. There was no correlation between CTCAE and other testing results. A higher number of those receiving placebo had increased CTCAE sensory neuropathy scores compared to those on glutamine (p = 0.02) on day 21. There was no difference between groups on day 42. There were no differences between groups in motor neuropathy scores.

Conclusions

Glutamine had a protective effect for sensory neuropathy in this study. Varied measures for peripheral neuropathy were not correlated, pointing to the need for ongoing research to identify the most valid and reliable measures for assessment.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • The glutamine group had lower sensory neuropathy scores at baseline.

Nursing Implications

There have been mixed findings regarding the benefits of glutamine for the prevention of chemotherapy-induced peripheral neuropathy. This study demonstrated some benefit, although limited by sample size. Ongoing research is needed for determination of any potential role of glutamine for the prevention of neuropathy with agents associated with this side effect.