Hershman, D.L., Unger, J.M., Crew, K.D., Minasian, L.M., Awad, D., Moinpour, C.M., . . . Albain, K.S. (2013). Randomized double-blind placebo-controlled trial of acetyl-L-carnitine for the prevention of taxane-induced neuropathy in women undergoing adjuvant breast cancer therapy. Journal of Clinical Oncology, 31, 2627-2633.

To determine if acetyl-L-carnitine (ALC) prevents chemotherapy-induced peripheral neuropathy (CIPN) in women with early stage breast cancer receiving taxane-based treatment

Patients were randomly assigned to receive either placebo or ALC 3,000 mg (6 capsules) daily for 24 weeks.

• N = 409 (final sample); 208 received ALC and 201 received placebo
• MEDIAN AGE = 51 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Women with stage I-II breast cancer who were to receive adjuvant taxane therapy

• SITE: Multi-site 
• SETTING TYPE: Outpatient

PHASE OF CARE: Active antitumor treatment

Randomized, double-blind, placebo-controlled

• Neurotoxicity component of the Functional Assessment of Cancer Therapy–Taxane scale (FACT-NTX)
• Functional Assessment of Cancer Therapy–Taxane Trial Outcome Index (FACT-TOI)
• Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue)

At week 12,  patients taking ALC had lower FACT-NTX scores (0.9), indicating more CIPN than those taking placebo (P = .17). After 24 weeks, patients taking ALC had a greater than 5-point decrease in FACT-NTX scores (P = .05). The FACT-TOI scores were lower with ALC (P = .03 ). There was no difference in the FACIT-Fatigue score between arms. Patients reported grade 3-4 neuropathy in the ALC arm versus grade 1 reported in the placebo arm resulting from taxane (P = .46).

At the end of 24 weeks, patients who had been taking ALC reported an increase in CIPN and a decrease in function, compared to those taking placebo.

• Subject withdrawals were ≥ 10%.
• Since this study was done with a taxane-based chemotherapy, it is unknown how other neurotoxic drugs given with ALC would influence CIPN.
• The scores at 24 weeks represented the main secondary endpoint and not the primary endpoint; however, since not all patients had completed the taxane treatment at 12 weeks from when they were registered, 24 weeks may have been the most appropriate endpoint after all.
• Since this trial indicated a detrimental effect with ALC and a taxane, it is recommended that a taxane-based chemotherapy and ALC trial not be repeated.

It has been reported in the literature that many patients take supplements without any evidence of efficacy. Patients often have discussions with nurses and ask questions about the use of supplements. To give patients correct information, including the risks, nurses need to be knowledgeable about the efficacy of nutritional supplements. It is recommended, from the results of this study, that nurses discourage patients from taking ALC since it may be harmful.