A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome
I. To determine whether omega-3 fatty acids can prevent or ameliorate paclitaxel associated
pain syndrome (P-APS) in cancer patients.
I. To determine whether omega-3 fatty acids can prevent development of peripheral
II. To assess tolerability of omega -3 fatty acids in this setting. III. To compare quality
of life (QOL) with omega 3 fatty acids supplementation versus placebo.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive omega-3 fatty acid orally (PO) once daily (QD) or twice daily (BID)
for 12 weeks.
ARM II: Patients receive placebo PO QD or BID for 12 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Mean severity of pain
Differences between groups will analyzed via t-tests or Wilcoxon rank-sum tests as appropriate.
Up to 1 month after completion of therapy
University of New Mexico Cancer Center
United States: Food and Drug Administration
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|
|Presbyterian Medical Group||Albuquerque, New Mexico 87110|