Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000149965
Ethics application status
Approved
Date submitted
3/02/2011
Date registered
8/02/2011
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture for treatment of joint pain secondary to aromatase inhibitor therapy in women with early breast cancer
Scientific title
Feasibility of use of acupuncture for treatment of arthralgia secondary to aromatase inhibitor therapy in women with early breast cancer
Secondary ID [1] 253539 0
X09-0023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthralgia secondary to aromatase inhibitor 261100 0
Breast Cancer 261127 0
Condition category
Condition code
Cancer 259233 259233 0 0
Breast
Musculoskeletal 259240 259240 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture twice weekly for 6 weeks. The sites which will be used are L14, LI11, GB34, ST40, Du20, Shishencong and Baxie on Day 1(First Session) and GB21, ST36, TH5, SP6 and LIV3 on Day 2 (Second Session). In the treatment group the needles will be inserted with bilateral rotation until "de Qi" sensation is elicited. Electrical frequency will then be delivered over 2 to 10 Hz (as tolerated by the participant, 0.5 to 0.7 milliseconds duration pulse width for twenty minutes. Each session will take 30-60 minutes.
Intervention code [1] 257969 0
Treatment: Other
Comparator / control treatment
Sham acupuncture will be given twice weekly for 6 weeks following the same schedule as the treatment group. Treatment will consist of bilateral manipulation using the specially designed non-skin penetrating devices (which automatically retract on contact with the skin) placed at points close to the real acupoints in the study, which produce pinpoint pressure sensation. The electroacupuncture machine will deliver the same audiovisual stimuli as in the electroacupuncture treatment arm, but lead wires will be concealed and disconnected so no electrial current is passed to the needles.
Control group
Placebo

Outcomes
Primary outcome [1] 262065 0
Feasibility and safety of acupuncture versus sham acupuncture. Benefit of acupuncture to reduce symptoms and pain associated with arthralgia related to adjuvant aromatase inhibitor therapy. Assessments will be measured by a research assistant blinded to the baseline measurements.To ensure a comprehensive evaluation of the patient's symptoms, both self report and a clinical examination will be utilised. Baseline self assessment will involve 4 short questionnaires: the BPI-SF, WOMAC, FACT-G and FACT-Cog which will collectively assess severity of pain, evaluate impact of pain on quality of life and determine social and emotional well being. Bloods to meausre markers of inflammation (ESR, CRP) will be performed before and after 6 weeks of treatment
Timepoint [1] 262065 0
End of acupuncture and 6 weeks post acupuncture
Secondary outcome [1] 273140 0
Nil
Timepoint [1] 273140 0
Nil

Eligibility
Key inclusion criteria
Early breast cancer patients taking thrid generaion aromatase inhibitor.
Women with ongoing pain and/or stiffness in one or more joints which worsened after starting aromatase inhibitor.
Baseline worst pain score on BPI-SF of 3 or greater (scale 0-10)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous use of acupuncture for Aromatase Inhibitor induced joint paint
Severe concomitant illness or metastatic breast cancer
Severe coagulopathy or bleeding disorder or dermatological disease within the acupuncture area (including patients on warfarin or low molecular weight heparin).
Patients with cardiac pacemakers, defibrilator or any other implanted or topical electrical device.
Needle phobia rendering a patient unable to receive acupuncture.
Patients with intellectual or mental impairment

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)
The patient's medical oncologist will identify patients and discuss the trial with them. They will be given opportunity to read the patient information and consent forms and ask questions. The medical oncologist and the research assistant will both check eligibility
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list will be computer generated a a person not involved with the project will prepare numbered opaque envelopes with the allocation grouup sealed inside. The randomisation process should distribute equally to the two groups (acupuncture or sham acupuncte)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258426 0
Government body
Name [1] 258426 0
Cancer Institute NSW Innovation Grant
Country [1] 258426 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 257574 0
None
Name [1] 257574 0
Address [1] 257574 0
Country [1] 257574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260405 0
Sydney South West Area Health Service (RPA Zone)
Ethics committee address [1] 260405 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Ethics committee country [1] 260405 0
Australia
Date submitted for ethics approval [1] 260405 0
25/02/2009
Approval date [1] 260405 0
25/06/2009
Ethics approval number [1] 260405 0
HREC/09/RPAH/33

Summary
Brief summary
Breast cancer is most common cancer in women. Aproximately 75% of patients diagosed will have hormone receptor positive breast cancer. Tamoxifen has long been considered the gold standard for adjuvant therapy for postmenopausal women with endocrine sensitive early breast cancer. Aromatase inhibitors (AIs) are commonly used and are in fact superior in improving disease free survival. As a result, it is expected that in coming years the use of AIs in the current setting will increase dramatically. However, trials of AIs for breast cancer treatment have indicated that more than 40% of women taking AIs experience joint pain and stiffness which doesn't respond to conventional pain medication and may cause discontinuation of AI treatment. Acupuncture is one such alternative technique currentlyused for treating a variety of conditions including musculoskeletal pain. The analgesic mechanism of acupuncture is uncertain but it is speculated that analgesia may be mediated by release of opiod peptides and serotonin.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32165 0
Address 32165 0
Country 32165 0
Phone 32165 0
Fax 32165 0
Email 32165 0
Contact person for public queries
Name 15412 0
Dr Jane Beith
Address 15412 0
Department of Medical Oncology
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 15412 0
Australia
Phone 15412 0
+61 2 95158304
Fax 15412 0
Email 15412 0
jane.beith@sswahs.nsw.gov.au
Contact person for scientific queries
Name 6340 0
Dr Jane Beith
Address 6340 0
as above
Country 6340 0
Australia
Phone 6340 0
+61 2 95158304
Fax 6340 0
Email 6340 0
jane.beith@sswahs.nsw.gov.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.