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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.