Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000607875
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
6/06/2012
Date last updated
6/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture to reduce symptoms of lymphoedema in women recovering from breast cancer
Scientific title
Can acupuncture compared with usual care reduce symptoms of lymphoedema in women recovering from breast cancer: a feasibility study
Secondary ID [1] 280622 0
Nil
Universal Trial Number (UTN)
U1111-1131-4745
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema following breast cancer 286634 0
Condition category
Condition code
Alternative and Complementary Medicine 286917 286917 0 0
Other alternative and complementary medicine
Cancer 286918 286918 0 0
Breast
Cardiovascular 286930 286930 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture. Twelve treatments will be administered over 8 weeks. Twice weekly for four weeks and weekly for four weeks.

Treatment wll be administered over 45 minutes.
The acupuncture points used include a selection of three points from Ren 12, 3, 2, LI15, TH4, LU5, LI4. ST36, SP9, SP6, and additional points from the subjects differential diagnosis.
Intervention code [1] 285021 0
Treatment: Other
Comparator / control treatment
Usual care defined as their regular routine for the management of the lympoedema. This may include regular use of a compression garment. No additional active treatment is to be sought during the three months in the study.
Control group
Active

Outcomes
Primary outcome [1] 287273 0
Volume of extracellular fluid will be assessed using bioimpedance spectroscopy.
Timepoint [1] 287273 0
Weekly for eight weeks consecutively, and at 12 weeks
Primary outcome [2] 287275 0
Arm circumference will be measured from the ulnar styloid at 10 cm intervals.
Timepoint [2] 287275 0
Weekly for eight weeks consecutively, and at 12 weeks
Secondary outcome [1] 297803 0
Lymphoedema Symptom Intensity and Distress Survey-Arm and Trunk.
Timepoint [1] 297803 0
Baseline, 8 and 12 weeks.
Secondary outcome [2] 297805 0
Change in lymphoedema symptoms will be assessed using a scale developed by Norman (adapted from the Memorial Symptom Assessment Scale).
Timepoint [2] 297805 0
Baseline, 8 and 12 weeks.
Secondary outcome [3] 297806 0
Quality of life assessed using the self report MYMOP questionnaire.
Timepoint [3] 297806 0
Baseline, 8 and 12 weeks

Eligibility
Key inclusion criteria
Stable unilateral intransient lymphoedema is present for at least 6 months for women with a history of breast cancer, and:

No intensive therapy (ie decongestive therapy) within the past 3 months.

No infections in the lymphoedematous limb within the past 3 months requiring antibiotics, and no exacerbation that led to change in daily activities.

The BIS inter-limb threshold (determined in a healthy age-matched cohort accounting for limb dominance for at least one 10cm segment (commencing from the ulnar styloid and proceeding up to the axilla) will be exceeded.

Are available for two months –(i.e. not planning to travel or move in the next 6 months) and are able to attend an acupuncturist at least 3 times per week.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be excluded if they are currently receiving adjuvant therapy for breast cancer or they have previously received acupuncture for treatment of lymphoedema.

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)
Opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated by independent resercher.
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
14/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285383 0
University
Name [1] 285383 0
University of Western Sydney
Country [1] 285383 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith
NSW 2751
Country
Australia
Secondary sponsor category [1] 284241 0
None
Name [1] 284241 0
Address [1] 284241 0
Country [1] 284241 0
Other collaborator category [1] 276845 0
Individual
Name [1] 276845 0
Associate Professor Marie Pirotta
Address [1] 276845 0
Dept. General Practice
University of Melbourne
200 Berkeley Street
Carloton VIC 3053
Country [1] 276845 0
Australia
Other collaborator category [2] 276846 0
Individual
Name [2] 276846 0
Professor Sharon Kilbreath
Address [2] 276846 0
Faculty of Health Sciences
University of Sydney
C42 - Cumberland Campus
Lidcombe NSW 2141
Country [2] 276846 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287401 0
UNIVERSITY OF WESTERN SYDNEY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 287401 0
Research Services
University of Western Sydney
Locked Bag 1797
Penrith
NSW 2751
Ethics committee country [1] 287401 0
Australia
Date submitted for ethics approval [1] 287401 0
Approval date [1] 287401 0
27/04/2012
Ethics approval number [1] 287401 0
H9535

Summary
Brief summary
This study aims to determine whether acupuncture can reduce symptoms of lymphoedema (chronic swelling) in women recovering from breast cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had chronic swelling (lymphoedema) on one arm present for at least 6 months following treatment for breast cancer. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive 12 acupuncture treatments over a period of 8 weeks in a schedule of twice weekly for four weeks then once weekly for four weeks. Participants in the other group will continue to receive their usual care and will not undergo any acupuncture treatment. Participants will be assessed at regular intervals to determine how lymphoedema is affected by acupuncture over a course of treatment. This study will also determine the feasibility and safety of acupuncture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34270 0
Address 34270 0
Country 34270 0
Phone 34270 0
Fax 34270 0
Email 34270 0
Contact person for public queries
Name 17517 0
Caroline Smith
Address 17517 0
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Penrith
NSW 2751
Country 17517 0
Australia
Phone 17517 0
+61 2 4620 3777
Fax 17517 0
Email 17517 0
[email protected]
Contact person for scientific queries
Name 8445 0
Caroline Smith
Address 8445 0
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Penrith
NSW 2751
Country 8445 0
Australia
Phone 8445 0
+61 2 4620 3777
Fax 8445 0
Email 8445 0
[email protected]

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.