None listed
Conditions
Brief 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.
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 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 applie
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.
Sponsors
Breast Cancer Research Centre of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
1. ECOG 0-1 2. Post menopausal early breast cancer patients with endocrine- responsive disease who are recommended for an aromatase inhibitor and have received an aromatase inhibitor for a minimum of 3 months and is planned to continue on the same aromatase inhibitor for at least a further 6 months 3. Prior adjuvant chemotherapy (including trastuzumab and bevacizumab) are permitted 4. Joint pain +/- stiffness in one or more joints which has subjectively worsened whilst on an aromatase inhibitor 5. Able to complete a joint pain severity and stiffness assessment using a 5-point visual analogue score and ability to complete the BPI assessment tool 6. Patients consent to not commencing any other, topical or non-steroidal strategy aimed specifically at alleviating arthralgia during study period. However, oral analgesics are permitted.
Exclusion criteria
1. Hypersensitivity to oleic acid or linolenic acid 2. Rheumatoid arthritis or any arthritic disease (with exclusion of osteoarthritis) 3. Patients who have received immunosuppressant medication or corticosteroids within the preceding 3 months (inhaled corticosteroids are permitted eg inhalers for asthma) 4. Patients who are receiving any topical medicine for joint stiffness or pain 5. Any other clinical condition that contradicts the use of the investigational agent (eg. Hypersensitivity or allergy to any ingredients of either oil) or that may affect patients compliance with study routines or place the patient at high risk from treatment complications
Outcome results
None listed