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Trial registered on ANZCTR


Registration number
ACTRN12611000019909
Ethics application status
Approved
Date submitted
1/12/2010
Date registered
6/01/2011
Date last updated
26/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Emu oil for joints pain in postmenopausal women with early breast cancer
Scientific title
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
Secondary ID [1] 253208 0
nil
Universal Trial Number (UTN)
Trial acronym
JUST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arthralgic pain related to aromatase inhibitors 258735 0
Condition category
Condition code
Cancer 258886 258886 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257680 0
Treatment: Drugs
Comparator / control treatment
Placebo oil (250mL) consists of:
Shea butter 43g
Medium Chain Triglycerides 30g
Almond Oil (Sweet) 190g
Carrot Oil blend 0.35g.
1.25mL of oil is applied three times daily for 8 weeks in phase A and 8 weeks in phase B
Control group
Placebo

Outcomes
Primary outcome [1] 259748 0
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
Timepoint [1] 259748 0
Baseline through end of 8 weeks of treatment
Primary outcome [2] 259772 0
Change in pain severity using visual analogue score from baseline to week 8
Timepoint [2] 259772 0
From baseline to week 8
Primary outcome [3] 259773 0
Change in pain severity using visual analogue score from baseline to week 8
Timepoint [3] 259773 0
From baseline to week 8
Secondary outcome [1] 266498 0
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
Timepoint [1] 266498 0
Baseline through end of 8 weeks of treatment
Secondary outcome [2] 266499 0
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
Timepoint [2] 266499 0
Baseline through end of treatment
Secondary outcome [3] 266500 0
Compliance with application of emu oil will be measured using a patient daily diary, which is to be assessed by site staff
Timepoint [3] 266500 0
Baseline through end of treatment
Secondary outcome [4] 266501 0
To assess overall pain at the end of 8 weeks using the Brief Pain Inventory assessment
Timepoint [4] 266501 0
Baseline through end of 8 weeks of treatment

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a double blind palcebo controlled study. Following informed consent, patients will be assessed for joint pain and stiffness. Once patients are enrolled, they will be randomized (1:1) to a drug kit number. Each kit will contain 1 bottle named 'A' for phase A and 1 bottle name 'B' for phase B. 'A' bottles will be either emu oil or placebo oil and 'B' bottles will be open label emu oil. Each kit will be assigned a unique identification code and all bottles within the kit will have the same number. Sites will be notified of the kit number for a particular patient by return of enrollment/ randomization fax. At start of the treatment, patients will receive bottle 'A' only for 8 weeks of treatment. Following 8 weeks of treatment, if patient voluntarily decide to continue on unblinded phase, bottle 'B' will be provided.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification will be based on 1) centre 2) Received chemotherapy yes vs. no.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase A: Subjects receiving blinded emu oil or placebo oil in Parallel design. Phase B: all subjects will be able to crossover to open-label emu oil
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 4370 0
Epworth Freemasons - Melbourne
Recruitment hospital [2] 4371 0
Breast Cancer Research Centre - Western Australia - Perth
Recruitment hospital [3] 7878 0
Epworth Freemasons - Melbourne
Recruitment hospital [4] 7879 0
Breast Cancer Research Centre - Western Australia - Perth
Recruitment postcode(s) [1] 9726 0
6000 - Perth
Recruitment postcode(s) [2] 9727 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 258161 0
Commercial sector/Industry
Name [1] 258161 0
Novartis Pharmaceuticals Pty Ltd
Address [1] 258161 0
54 Waterloo Road
North Ryde NSW 2113
Country [1] 258161 0
Australia
Funding source category [2] 258233 0
Commercial sector/Industry
Name [2] 258233 0
Novartis Pharmaceutical Australia Pty Ltd
Address [2] 258233 0
54 Waterloo Road
North Ryde NSW 2113
Country [2] 258233 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breast Cancer Research Centre of Western Australia
Address
Hollywood Private Hospital, Lower Ground Floor, Entrance 3, 101 Monash Avenue, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 257440 0
None
Name [1] 257440 0
Address [1] 257440 0
Country [1] 257440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260136 0
Mount Hospital Ethics Committee
Ethics committee address [1] 260136 0
150 Mounts Bay Rd, Perth WA 6000
Ethics committee country [1] 260136 0
Australia
Date submitted for ethics approval [1] 260136 0
Approval date [1] 260136 0
04/08/2010
Ethics approval number [1] 260136 0
EC53.1

Summary
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.
Trial website
Trial related presentations / publications
Chan A, De Boer R, Gan A, Willsher P, Martin R, Zissiadis Y, Miller K, Bauwens A, Hastrich D et al Randomized phase II placebo-controlled study to evaluate the efficacy of topical pure emu oil for joint pain related to adjuvant aromatase inhibitor use in postmenopausal women with early breast cancer: JUST (Joints Under Study). Support Care Cancer. 2017:Jul 9. doi: 10.1007/s00520-017-3810-9
Public notes

Contacts
Principal investigator
Name 31959 0
Prof Arlene Chan
Address 31959 0
Breast Cancer Research Centre of Western Australia
Breast Clinical Trials Unit
suite 40, 146 Mounts Bay Road, Perth WA 6000
Country 31959 0
Australia
Phone 31959 0
+61 8 9483 4643
Fax 31959 0
Email 31959 0
admin.profachan@me.com
Contact person for public queries
Name 15206 0
Mrs Jeannette Devoto
Address 15206 0
Breast Clinical Trials Unit, Hollywood Private Hospital, Lower Ground Floor, Entrance 3, 101 Monash Avenue, Nedlands WA 6009
Country 15206 0
Australia
Phone 15206 0
+61-8-6500 5555
Fax 15206 0
+ 61 -8-6500 5599
Email 15206 0
BCTU@bcrc-wa.com.au
Contact person for scientific queries
Name 6134 0
Mrs Jeannette Devoto
Address 6134 0
Breast Clinical Trials Unit, Hollywood Private Hospital, Lower Ground Floor, Entrance 3, 101 Monash Avenue, Nedlands WA 6009
Country 6134 0
Australia
Phone 6134 0
+61-8-6500 5555
Fax 6134 0
+61-8-6500 5599
Email 6134 0
BCTU@bcrc-wa.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary