Maestri, A., De Pasquale Ceratti, A., Cundari, S., Zanna, C., Cortesi, E., & Crino, L. (2005). A pilot study on the effect of acetyl-L-carnitine in paclitaxel- and cisplatin-induced peripheral neuropathy. Tumori, 91, 135–138.

Intervention Characteristics/Basic Study Process

Patients were treated with acetyl-L-carnitine (ALC) 1 g per day via IV for at least 10 consecutive days. Cisplatin neuropathy was characterized as numbness, tingling, loss of vibration sensation, and diminished proprioception.

Sample Characteristics

  • The sample consisted of 27 patients with paclitaxel- or cisplatin-induced chemotherapy-induced peripheral neuropathy (CIPN) aged 48–75 years.
  • Potential participants were excluded if they had a European Cooperative Oncology Group performance status greater than 2 or preexisting neuropathy (not CIPN).

Setting

The study was conducted from April 2000 to December 2002.

Measurement Instruments/Methods

  • CIPN severity was graded using the World Health Organization toxicity grading scale.
  • Clinical neurologic assessment was preformed at baseline and at the end of ALC treatment.

Results

Of the 26 patients, 19 (73%) showed at least one grade of CIPN improvement, and all cisplatin-treated patients showed at least one grade of CIPN improvement. In addition, one patient with World Health Organization grade 2 neuropathy had complete resolution of neuropathy after 11 days of treatment. For paclitaxel-treated patients, 8 of 12 (67%) showed one grade improvement, as did 8 of 10 (80%) in the combination paclitaxel and cisplatin treatment group. The remaining patients had stable CIPN.

Limitations

  • Limitations included a small sample size (27 enrolled, 26 with data for analysis); the non-randomized, non-blinded design; and no control group, because of which no causality can be inferred.
  • Whether the clinical neurologic examinations were conducted by the same physician using a standard approach or by different practitioners is unclear.
  • No information concerning inter- or intrarater reliability was provided.
  • The parameters tested and methods used to conduct the clinical neurologic testing was not provided.
  • The number of variables used in the statistical tests also are unknown, making it difficult to evaluate the conclusions.