Eckel, F., Schmelz, R., Adelsberger, H., Erdmann, J., Quasthoff, F., & Lersch, C. (2002). [Prevention of oxaliplatin-induced neuropathy by carbamazepine. A pilot study]. Deutsche Medizinische Wochenschrift, 127(3), 78–82.

DOI Link

Intervention Characteristics/Basic Study Process

Carbamazepine was tested in the prevention of chemotherapy-induced perihpheral neuropathy (CIPN) in 10 of 40 patients receiving oxaliplatin, folinic acid, and 5-FU chemotherapy. Ten patients also received carbamazapine 200 mg orally. Carbamazepine 200–600 mg was administered orally, with doses adapted to serum levels of 3-6 mg/l starting the week prior to treatment for two days, increased dose to 600 mg orally, and then doses were titrated to meet serum levels of 3-6 mg/l. Carbamazapine was administered until the end of oxaliplatin therapy, but if CIPN symptoms continued, carbamazepine also was continued until symptoms dissipated.

Sample Characteristics

  • A total of 40 pretreated patients with advanced colorectal cancer received combination chemotherapy with oxaliplatin 85 mg/m² on days 1, 15, and 29.
  • Folic acid 500 mg/m² and 5-FU 2,000 mg/m² were given on days 1, 8, 15, 22, 29, and 36.

Study Design

The study was a non-randomized pilot design.

Measurement Instruments/Methods

  • Weekly neurologic examinations measured vibratory sensibility of the plantar surfaces of feet and hands by a tuning fork, cold-induced symptoms, and documentation of side effects.
  • Neuropathy also was assessed by the World Health Organization toxicity grading scale.

Results

No WHO grade 2-4 neuropathy was found in the patients treated with carbamazepine compared to 30% who experienced grade 2-4 neuropathy in a historical control group.

Limitations

  • The study's non-randomized, non-blinded design was a limitation, as was the use of a historical comparison group.
  • The very small sample size of 10 participants precludes comparison of group differences.
  • Study methods and analysis were not well described.