CompletedPhase 2ACTRN12611000019909

Emu oil for joints pain in postmenopausal women with early breast cancer

Phase II randomised, 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: JUST joints under pain


Sponsor

Breast Cancer Research Centre of Western Australia

Enrollment

75 participants

Start Date

Dec 3, 2010

Study Type

Interventional

Conditions

Summary

This study looks at the effectiveness of pure emu oil for treatment of joints pain in postmenopausal women receiving treatment with aromatase inhibitors due to early breast cancer. This is a 2 phase study, where phase 'A ' is blinded and phase 'B' is open labelled (not blinded). In first phase, participants will be randomized to receive either emu oil or placebo for 8 weeks and the arm to which they are randomized will not be known to them or their doctor. During this treatment period, all patients would be required to mainatain daily diary to record treatment compliance. Joint pain and stiffness severity will be assessed before and after treatment using pain questionnaires. In phase B, patients will be asked to continue treatment with open label emu oil for further 8 weeks, if they wish. All patients continuing in phase B, will be assessed for pain and stiffness severity at the end of this phase. Following 16 weeks of treatment, patients will be able to continue with commercial stock of emu oil, and will be assessed for compliance and severity at 6 months. Improvement in joint pain and stiffness will be assessed at baseline and end of 8 weeks of treatment. Adverse events and compliance related to Emu oil will be monitored throughout the study. Overall pain will be assessed at baseline and end of 8 weeks of treatment.


Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This study tests whether emu oil applied to the skin can relieve joint pain and stiffness in postmenopausal women with early breast cancer who are taking aromatase inhibitor medications. These medications are known to cause joint discomfort as a side effect, and researchers want to see if emu oil offers relief.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Pure EMU oil: Subjects will be randomised in 1:1 ratio to receive either emu oil (investigational product) or placebo in phase A (double blind phase). In phase B, subjects may voluntary decide to cont

Pure EMU oil: Subjects will be randomised in 1:1 ratio to receive either emu oil (investigational product) or placebo in phase A (double blind phase). In phase B, subjects may voluntary decide to continue treatment with open label emu oil. For phase A, 1.25mL of oil (emu oil or placebo) will be applied topically to selected joints three times daily for 8 weeks, followed by 1.25mL of open-label emu oil applied topically to selected joints for 8 weeks in phase B. During Phase B, oil will be applied three times daily. Phase B will commence immediately from Phase A.


Locations(4)

Epworth Freemasons - Melbourne

WA,VIC, Australia

Breast Cancer Research Centre - Western Australia - Perth

WA,VIC, Australia

Epworth Freemasons - Melbourne

WA,VIC, Australia

Breast Cancer Research Centre - Western Australia - Perth

WA,VIC, Australia

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ACTRN12611000019909