ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

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]

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]

Baseline through end of 8 weeks of treatment

Primary outcome [2]

Change in pain severity using visual analogue score from baseline to week 8

Timepoint [2]

From baseline to week 8

Primary outcome [3]

Change in pain severity using visual analogue score from baseline to week 8

Timepoint [3]

From baseline to week 8

Secondary outcome [1]

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]

Baseline through end of 8 weeks of treatment

Secondary outcome [2]

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]

Baseline through end of treatment

Secondary outcome [3]

Compliance with application of emu oil will be measured using a patient daily diary, which is to be assessed by site staff

Timepoint [3]

Baseline through end of treatment

Secondary outcome [4]

To assess overall pain at the end of 8 weeks using the Brief Pain Inventory assessment

Timepoint [4]

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

Sex

Females

Can healthy volunteers participate?

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

1/12/2010

Actual

3/12/2010

Date of last participant enrolment

Anticipated

Actual

26/02/2015

Date of last data collection

Anticipated

Actual

29/07/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

WA,VIC

Recruitment hospital [1]

Epworth Freemasons - Melbourne

Recruitment hospital [2]

Breast Cancer Research Centre - Western Australia - Perth

Recruitment hospital [3]

Epworth Freemasons - Melbourne

Recruitment hospital [4]

Breast Cancer Research Centre - Western Australia - Perth

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

3002 - East Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Novartis Pharmaceuticals Pty Ltd

Address [1]

54 Waterloo Road
North Ryde NSW 2113

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Novartis Pharmaceutical Australia Pty Ltd

Address [2]

54 Waterloo Road
North Ryde NSW 2113

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mount Hospital Ethics Committee

Ethics committee address [1]

150 Mounts Bay Rd, Perth WA 6000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/08/2010

Ethics approval number [1]

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

Prof Arlene Chan

Address

Breast Cancer Research Centre of Western Australia
Breast Clinical Trials Unit
suite 40, 146 Mounts Bay Road, Perth WA 6000

Country

Australia

Phone

+61 8 9483 4643

Fax

admin.profachan@me.com

Contact person for public queries

Name

Jeannette Devoto

Address

Breast Clinical Trials Unit, Hollywood Private Hospital, Lower Ground Floor, Entrance 3, 101 Monash Avenue, Nedlands WA 6009

Country

Australia

Phone

+61-8-6500 5555

Fax

+ 61 -8-6500 5599

BCTU@bcrc-wa.com.au

Contact person for scientific queries

Name

Jeannette Devoto

Address

Breast Clinical Trials Unit, Hollywood Private Hospital, Lower Ground Floor, Entrance 3, 101 Monash Avenue, Nedlands WA 6009

Country

Australia

Phone

+61-8-6500 5555

Fax

+61-8-6500 5599

BCTU@bcrc-wa.com.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		DOI: 10.1002/pon.5294 Psycho-Oncology 2019; 1-8	336281-(Uploaded-14-01-2021-15-18-28)-Journal results publication.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

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