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

Phase 2

Completed

• Conditions: arthralgic pain related to aromatase inhibitors; Cancer - Breast

• Registration Number: ACTRN12611000019909
• Lead Sponsor: Breast Cancer Research Centre of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate an improvement in joint pain from baseline to end of 8 weeks of treatment using visual analogue score and Brief Pain Inventory assessments[Baseline through end of 8 weeks of treatment];Change in pain severity using visual analogue score from baseline to week 8[From baseline to week 8];Change in pain severity using visual analogue score from baseline to week 8[From baseline to week 8]

Secondary Outcome Measures

Name	Time	Method
To demonstrate an improvement in joint stiffness from baseline to end of 8 weeks of treatment using categorical scale of nil through to severe, measured on a 4-point categorical scale[Baseline through end of 8 weeks of treatment];The anticipated adverse effects of topical emu oil and placebo or unknown, but anticipated to be only of low grade severity. All adverse events related to the use of emu oil (or placebo) will be graded using CTCAE4.0[Baseline through end of treatment];Compliance with application of emu oil will be measured using a patient daily diary, which is to be assessed by site staff[Baseline through end of treatment];To assess overall pain at the end of 8 weeks using the Brief Pain Inventory assessment[Baseline through end of 8 weeks of treatment]