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Supportive Care in Cancer

, Volume 19, Issue 6, pp 833–841 | Cite as

A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA

  • Debra L. Barton
  • Edward J. Wos
  • Rui Qin
  • Bassam I. Mattar
  • Nathan Benjamin Green
  • Keith S. Lanier
  • James Dewitt BeardenIII
  • John W. Kugler
  • Kay L. Hoff
  • Pavan S. Reddy
  • Kendrith M. RowlandJr
  • Mike Riepl
  • Bradley Christensen
  • Charles L. Loprinzi
Original Article

Abstract

Background

Chemotherapy-induced peripheral neuropathy (CIPN) is a troublesome chronic symptom that has no proven pharmacologic treatment. The purpose of this double-blind randomized placebo-controlled trial was to evaluate a novel compounded topical gel for this problem.

Methods

Patients with CIPN were randomized to baclofen 10 mg, amitriptyline HCL 40 mg, and ketamine 20 mg in a pluronic lecithin organogel (BAK-PLO) versus placebo (PLO) to determine its effect on numbness, tingling, pain, and function. The primary endpoint was the baseline-adjusted sensory subscale of the EORTC QLQ-CIPN20, at 4 weeks.

Results

Data in 208 patients reveal a trend for improvement that is greater in the BAK-PLO arm over placebo in both the sensory (p = 0.053) and motor subscales (p = 0.021). The greatest improvements were related to the symptoms of tingling, cramping, and shooting/burning pain in the hands as well as difficulty in holding a pen. There were no undesirable toxicities associated with the BAK-PLO and no evidence of systemic toxicity.

Conclusion

Topical treatment with BAK-PLO appears to somewhat improve symptoms of CIPN. This topical gel was well tolerated, without evident systemic toxicity. Further research is needed with increased doses to better clarify the clinical role of this treatment in CIPN.

Keywords

CIPN Topical gel BAK-PLO 

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Copyright information

© Springer-Verlag 2010

Authors and Affiliations

  • Debra L. Barton
    • 1
  • Edward J. Wos
    • 2
  • Rui Qin
    • 1
  • Bassam I. Mattar
    • 3
  • Nathan Benjamin Green
    • 4
  • Keith S. Lanier
    • 5
  • James Dewitt BeardenIII
    • 6
  • John W. Kugler
    • 7
  • Kay L. Hoff
    • 8
  • Pavan S. Reddy
    • 3
  • Kendrith M. RowlandJr
    • 9
  • Mike Riepl
    • 10
  • Bradley Christensen
    • 1
  • Charles L. Loprinzi
    • 1
  1. 1.Mayo Clinic College of MedicineRochester55905USA
  2. 2.Medcenter One Health SystemBismarckUSA
  3. 3.Wichita CCOPWichitaUSA
  4. 4.Missouri Valley Cancer Consortium CCOPOmahaUSA
  5. 5.Providence Oncology and Hematology Care ClinicPortlandUSA
  6. 6.Spartanburg Regional Medical CenterSpartanburgUSA
  7. 7.Illinois CancerCarePeoriaUSA
  8. 8.Cancer Resource CenterLincolnUSA
  9. 9.Carle Cancer CenterUrbanaUSA
  10. 10.Gateway Health Mart PharmacyBismarckUSA

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