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Sunday, September 1, 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

  1. Frank L. Meyskens andKathy S. Albain
+ Author Affiliations
  1. Dawn L. Hershman, Katherine D. Crew, Danielle Awad, and Heather Greenlee, Columbia University Medical Center, New York, NY; Joseph M. Unger and Danika L. Lew, Southwest Oncology Group Statistical Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Lori M. Minasian, National Cancer Institute, Bethesda, MD; Lisa Hansen, Legacy Good Samaritan Hospital, Portland, OR; Louis Fehrenbacher, Kaiser Permanente Northern California, Vallejo; Siu-Fun Wong, Loma Linda University School of Pharmacy, Loma Linda; Frank L. Meyskens, University of California at Irvine, Orange, CA; James L. Wade III, Central Illinois Community Clinical Oncology Program/Cancer Care Specialists of Central Illinois, Decatur, IL; Gabriel N. Hortobagyi, MD Anderson Cancer Center, Houston, TX; and Kathy S. Albain, Loyola University Chicago Stritch School of Medicine, Maywood, IL.
  1. Corresponding author: Dawn L Hershman, MD, MS, Columbia University, 161 Fort Washington Ave, 10-1068, New York, NY 10032; e-mail: dlh23@columbia.edu.

Abstract

Purpose Chemotherapy-induced peripheral neuropathy (CIPN) is common and leads to suboptimal treatment. Acetyl-L-carnitine (ALC) is a natural compound involved in neuronal protection. Studies have suggested ALC may be effective for the prevention and treatment of CIPN. 

Patients and Methods A 24-week randomized double-blind trial comparing ALC (3,000 mg per day) with placebo in women undergoing adjuvant taxane-based chemotherapy was conducted. The primary objective was to determine if ALC prevents CIPN as measured by the 11-item neurotoxicity (NTX) component of the Functional Assessment of Cancer Therapy (FACT) –Taxane scale at 12 weeks. Secondary objectives included changes in 24-week end points, functional status (FACT–Trial Outcome Index [TOI]), fatigue (Functional Assessment of Chronic Illness Therapy [FACIT] –Fatigue), and NTX grade. 

Results A total of 409 patients were evaluable (208 received ALC; 201, placebo). In a multivariate linear regression, week-12 scores were 0.9 points lower (more CIPN) with ALC than placebo (95% CI, −2.2 to 0.4; P = .17), whereas week-24 scores were 1.8 points lower with ALC (95% CI, −3.2 to −0.4; P = .01). Patients receiving ALC were more likely to have a > 5-point decrease in FACT-NTX scores (38% v 28%; P = .05), and FACT-TOI scores were 3.5 points lower with ALC (P = .03). Grade 3 to 4 neurotoxicity was more frequent in the ALC arm (eight v one). No differences between arms were observed for FACIT-Fatigue or other toxicities. Serum carnitine level increased with ALC but remained stable with placebo. 

Conclusion There was no evidence that ALC affected CIPN at 12 weeks; however, ALC significantly increased CIPN by 24 weeks. This is the first study to our knowledge showing that a nutritional supplement increased CIPN. Patients should be discouraged from using supplements without proven efficacy.

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