Abstract
Aim. To evaluate the impact of acetyl-L-carnitine (ALC) administration on the incidence and severity of sensory and motor paclitxel-induced peripheral neuropathy (PIPN) in patients with breast cancer. Methods. Prospective, randomized, controlled study. Patients presenting to the Clinical Oncology Department, Ain Shams University, Cairo, were assessed for eligibility. Forty eligible patients with breast cancer were randomized to one of 2 groups. Control group (n=20) received three cycles of paclitaxel on a weekly dose schedule. Test group received the same regimen plus 1000 mg of oral ALC 3 times/ day for 12 weeks. Baseline evaluation included clinical examination, nerve conduction velocity (NCV) and serum nerve growth factor (NGF) estimation. Incidence and severity of sensory and motor PIPN and treatment related toxicity were assessed after each cycle using the common terminology criteria for adverse events (CTCAE) version 4, (2010). Results. In the 1st cycle, no significant difference was evident between both groups in frequency of sensory and motor PIPN. In the 2nd cycle and in the 3rd cycle, test group showed a significantly lower frequency of; sensory neuropathy and motor neuropathy versus control. At baseline, the median NGF levels were significantly lower in test group versus control. At the end of the study the median NGF levels were significantly lower in the control group versus their initial baseline levels. While, the test group median levels were higher than their baseline levels. The delta change in NGF was significantly different between the 2 groups. Conclusion Acetyl-l-carnitine administration led to a reduction in the frequency of motor and sensory PIPN, an improvement in NGF levels and was accompanied with less side effects and.
Highlights
Both groups were comparable in their baseline parameters with no significant difference between them except nerve growth factor (NGF) levels which were significantly lower in test group versus control group (Table 1)
At the end of the study, the median NGF levels were significantly lower (2.4, p=0.02) in the control group versus their initial baseline levels, while, the test group median levels were higher than their baseline levels
The current study aimed to evaluate the effect of ALC on peripheral neuropathy (PIPN) in Egyptian breast cancer patients To our knowledge, this is the first study to investigate the ALC neuroprotective effect in PIPN
Summary
All reported investigations in the current study have been carried out in accordance with the principles of the Declaration of Helsinki as revised in 2000. All patients were informed of study protocol and only those who gave a written informed consent were enrolled. A. Baseline Evaluation: At enrollment, through a face to face interview, the clinical pharmacist gathered the following information for both groups: a full history including medical, medication, family and social histories, laboratory investigation, full neurological examination including estimation of NCV, baseline education and estimation of NGF levels. Baseline education: For both groups: - Patients were given the follow up weekly side effects reporting card. - The follow up weekly card was used for patients’ self -assessment and reporting of the frequency and the severity of sensory and motor PIPN/ day during the 12 weeks period. - Patients were educated about using the follow up card, the expected signs and symptoms and how to report them. B. Follow up assessment: During the 12 weeks period, patients in both groups were assessed weekly as follows; 1.
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