title: Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  Chemotherapy-induced peripheral neuropathy is frequently a dose-limiting factor in cancer treatment and may cause pain and irreversible function loss in cancer survivors. We tested whether alpha-lipoic acid (ALA) could decrease the severity of peripheral neuropathy symptoms in patients undergoing platinum-based chemotherapy.
  
  
  METHODS
  Cancer patients 18 years or older were randomly selected to receive either 600 mg ALA or a placebo three times a day orally for 24 weeks while receiving chemotherapy regimens including cisplatin or oxaliplatin. Neuropathy was measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale and the NCI Common Toxicity Criteria for Adverse Events neurotoxicity grades. Results from timed functional tests and the Brief Pain Inventory (BPI) were secondary endpoints.
  
  
  RESULTS
  Seventy of 243 (29 %) patients completed the study (24 weeks). Both the ALA and the placebo arms had a comparable drop-out rate. No statistically significant differences were found between the ALA and the placebo groups for FACT/GOG-Ntx scores, BPI scores, and patients' functional outcomes.
  
  
  CONCLUSIONS
  This strategy of oral ALA administration was ineffective at preventing neurotoxicity caused by oxaliplatin or cisplatin. High attrition rates due to poor patient compliance and manner of dosage administration in this trial demonstrated a lack of feasibility for this intervention. Future studies to explore ALA as a neuroprotective agent should take heed of the barriers confronted in this study.
authors.affiliation: The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Unit 1414, Houston, TX, 77030, USA, yguo@mdanderson.org.
authors.forename: Ying
authors.initials: Y
authors.lastname: Guo
authors.forename: Desiree
authors.initials: D
authors.lastname: Jones
authors.forename: J Lynn
authors.initials: JL
authors.lastname: Palmer
authors.forename: Arthur
authors.initials: A
authors.lastname: Forman
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: Maria R
authors.initials: MR
authors.lastname: Velasco
authors.forename: Matthias
authors.initials: M
authors.lastname: Weiss
authors.forename: Paul
authors.initials: P
authors.lastname: Gilman
authors.forename: G M
authors.initials: GM
authors.lastname: Mills
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Noga
authors.forename: Cathy
authors.initials: C
authors.lastname: Eng
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Overman
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Fisch
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D020258:Neurotoxicity Syndromes / Q000209:etiology* / Q000517:prevention & control*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000175:diagnosis / Q000517:prevention & control*; D010919:Placebos; D008063:Thioctic Acid / Q000627:therapeutic use*
chemical_list: D009944:Organoplatinum Compounds; D010919:Placebos; D000077150:Oxaliplatin; D008063:Thioctic Acid; D002945:Cisplatin