R. Martin1, A. Chan1 1Mount Hospital Breast Cancer Research Centre
Overview:
The JUST trial is a Phase II, randomised, double blind, placebo-controlled study to evaluate the efficacy of topical pure Emu oil for arthralgic pain, related to aromatase inhibitor use in postmenopausal women with early breast cancer.
Background:
20% of patients using aromatase inhibitors for treatment of breast cancer cease them due to arthralgias and joint pains.
Emu oil has been shown to have topical anti-inflammatory effect in animal studies. A phase 1 trial has demonstrated 45% reduction in pain scores in 13 women applying Emu oil to affected joints after 8 weeks treatment.
Aim:
Using Visual Analogue Scores (VAS) we aim to demonstrate an improvement in joint pain as assessed from baseline to end of 8 weeks of treatment.
Secondary end points are to demonstrate an improvement in joint stiffness as assessed by a 4 point categorical scale from baseline to end of 8 weeks of treatment. We will also look at: Adverse effects related to the use of emu oil, compliance with application of Emu oil, and assess overall pain at the end of 8 weeks using the Brief Pain Inventory score
Methods:
~75 patients with joint pain subjectively worsening whilst on an aromatase inhibitor, randomized to receive either 250ml Emu Oil or 250ml placebo oil on a 1:1 basis. 1.25 ml oil applied over 30mins to up to 3 affected joints nominated at baseline. Baseline 5 point visual analogue scores completed with Brief pain inventory (BPI). Daily diary entry will be checked to ensure compliance, with final VAS and BPI scores completed at 8 weeks. At 8 weeks participants will be offered a further 8 weeks of treatment with open label Emu oil with VAS and BPI to be completed at the end of 16 weeks.
Accrual expected to be complete end February 2015. 72 patients will give 80% power to detect a 40% difference allowing for 25% placebo effect.