Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: a randomized double-blind placebo controlled trial.
BACKGROUND
Axonal sensory peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Omega-3 fatty acids have beneficial effects on neurological disorders from their effects on neurons cells and inhibition of the formation of proinflammatory cytokines involved in peripheral neuropathy.


METHODS
This study was a randomized double blind placebo controlled trial to investigate the efficacy of omega-3 fatty acids in reducing incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN). Eligible patients with breast cancer randomly assigned to take omega-3 fatty acid pearls, 640 mg t.i.d during chemotherapy with paclitaxel and one month after the end of the treatment or placebo. Clinical and electrophysiological studies were performed before the onset of chemotherapy and one month after cessation of therapy to evaluate PIPN based on "reduced Total Neuropathy Score".


RESULTS
Twenty one patients (70%) of the group taking omega-3 fatty acid supplement (n = 30) did not develop PN while it was 40.7%( 11 patients) in the placebo group(n = 27). A significant difference was seen in PN incidence (OR = 0.3, .95% CI = (0.10-0.88), p = 0.029). There was a non-significant trend for differences of PIPN severity between the two study groups but the frequencies of PN in all scoring categories were higher in the placebo group (0.95% CI = (-2.06 -0.02), p = 0.054).


CONCLUSIONS
Omega-3 fatty acids may be an efficient neuroprotective agent for prophylaxis against PIPN. Patients with breast cancer have a longer disease free survival rate with the aid of therapeutical agents. Finding a way to solve the disabling effects of PIPN would significantly improve the patients' quality of life.


BACKGROUND
This trial was registered at ClinicalTrials.gov (NCT01049295).
Department of Nutrition and Biochemistry, School of Health, Tehran University of Medical Sciences, Tehran, Iran.
Zohreh
Z
Ghoreishi
Ali
A
Esfahani
Abolghasem
A
Djazayeri
Mahmoud
M
Djalali
Banafsheh
B
Golestan
Hormoz
H
Ayromlou
Shahriar
S
Hashemzade
Mohammad
M
Asghari Jafarabadi
Vahid
V
Montazeri
Seyed Ali
SA
Keshavarz
Masoud
M
Darabi
D000328:Adult; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000150:complications / Q000188:drug therapy; D019587:Dietary Supplements; D015525:Fatty Acids, Omega-3 / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009431:Neural Conduction / Q000187:drug effects; D018696:Neuroprotective Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017239:Paclitaxel / Q000009:adverse effects* / Q000627:therapeutic use; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D015525:Fatty Acids, Omega-3; D018696:Neuroprotective Agents; D017239:Paclitaxel