Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000720011
Ethics application status
Approved
Date submitted
25/02/2010
Date registered
31/08/2010
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture for the treatment of fatigue post cancer treatment: a pilot study
Scientific title
Acupuncture compared to placebo acupuncture and a wait list control for women with post breast cancer fatigue.
Secondary ID [1] 252174 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-treatment fatigue in women with breast cancer 256866 0
Condition category
Condition code
Cancer 257015 257015 0 0
Breast
Alternative and Complementary Medicine 257016 257016 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study group 1: Traditional acupuncture with primary acupuncture points Kidney 3, Stomach 36, Spleen 6, Conception Vessel 6. Colon 4. These points have been used in previous research suggesting a therapeutic effect on fatigue in general. In addition secondary points will be administered based on a diagnosis used in Traditional Chinese Medicine. This design is similar to for example a psychiatrist who may diagnose a patient with the same condition yet use a different intervention due to varying clinical features. Treatment will be administered twice weekly over the first three weeks and then weekly for the final three weeks. Duration of each treatment 45 minutes. Acupuncture needles will be inserted to tissue level and stimulated manually. The needles will be stimulated once more during this treatment session. Single-use disposable stainless steel needles (0.25 x 40mm for body acupuncture) will be used. All points will be located according to the World Health Organisation International Standard Acupuncture Point Locations that was agreed on at Tsukuba, Japan, November, 2006. The intervention commences four weeks post cancer treatment.
Intervention code [1] 256061 0
Other interventions
Intervention code [2] 256898 0
Treatment: Other
Comparator / control treatment
Study group 2: The placebo group will use the Park Sham device which has a guide tube making it impossible for the subject to see whether the needle has penetrated the skin or not. The sham needle its self is able to slide into the handle, which increases the appearance that the skin has been penetrated. Needle penetration does not occur. The sham needle will be placed away from acupuncture points. The sham acupuncture device is an effective masking device for blinding in randomised controlled trials of acupuncture. Treatment will be administered twice weekly over the first three weeks and then weekly for the final three weeks, with each intervention lasting 45 minutes. The intervention commences four weeks post cancer treatment.

Study Group 3: Wait list control. Women randomised to this group will not receive any acupuncture during the six week trial. The research assistant will make contact with subjects at the assessment time. Women will be given the opportunity to receive acupuncture with the chief investigator following completion of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 257910 0
Fatigue measured by the Brief Fatigue Inventory
Timepoint [1] 257910 0
baseline, 2, 4 and 6 weeks.
Primary outcome [2] 258865 0
Quality of life measured by the Measure Yourself Medical Outcome Profile (MYMOP) questionnaire, and the Wellbeing Questionnaire-12.
Timepoint [2] 258865 0
baseline, 2, 4 and 6 weeks.
Secondary outcome [1] 263380 0
Examine women's perceptions and experiences of acupuncture using in depth interviews.
Timepoint [1] 263380 0
At the end of the trial
Secondary outcome [2] 264990 0
Safety measured by self report.
Timepoint [2] 264990 0
Following each treatment.

Eligibility
Key inclusion criteria
Women with a diagnosis of breast cancer, and a score of four or greater on the Brief fatigue inventory (BFI), completed cytotoxic chemotherapy at least one month previously, and the ability to provide informed written consent. The fatigue has to be associated with cancer treatment (experienced only since receiving treatment for breast cancer) and not general fatigue.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with severe anaemia defined as haemoglobin less than 9 g/dL or active treatment for anaemia, anticipated survival less than three months, no scheduled chemotherapy or radiotherapy during the study, fatigue prior to cancer diagnosis, or concurrent use of acupuncture.

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)
Screening for eligibility will be undertaken over the phone by the trial co-ordinator:
Women will need to be in the age range >18 years and <70 years with a history of a diagnosis of breast cancer. If women are eligible and interested in joining the study, an appointment will be made. Women will be randomly allocated to a study group by taking the next sequentially numbered sealed opaque envelope. Randomisation will be into three study groups, acupuncture, sham acupuncture and no acupuncture/wait list control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by a researcher not directly involved with the trial. The randomisation sequence will be computer generated. The sequence will be concealed and held in a locked filing cabinet at the Centre for Complementary Medicine Research.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2010
Actual
1/03/2010
Date of last participant enrolment
Anticipated
30/09/2010
Actual
28/02/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 256565 0
Government body
Name [1] 256565 0
Cancer Institute NSW
Country [1] 256565 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith South DC 1797
Country
Australia
Secondary sponsor category [1] 255861 0
University
Name [1] 255861 0
Centre for Complementary Medicine Research
Address [1] 255861 0
LG Building 5 Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith South DC 1797
Country [1] 255861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258600 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 258600 0
Locked Bag 1797
Penrith South DC 1797
Ethics committee country [1] 258600 0
Australia
Date submitted for ethics approval [1] 258600 0
Approval date [1] 258600 0
23/02/2010
Ethics approval number [1] 258600 0
H6697

Summary
Brief summary
This pilot study looks at the effectiveness of acupuncture to reduce fatigue in women after treatment for breast cancer. You can join this study if you have recently been treated for breast cancer with chemotherapy, and you are suffering from fatigue associated with this treatment. Participants will be divided into three groups: an acupuncture treatment group, a placebo acupuncture group and a wait-list control group. Both the acupuncture and the placebo acupuncture groups will receive a type of acupuncture twice weekly over the first three weeks and then weekly for the final three weeks, with each treatment lasting 45 minutes. The placebo group will use a device which has a guide tube making it impossible for the subject to see whether the needle has penetrated the skin or not. Needle penetration does not occur. The sham needle will be placed away from acupuncture points. The wait list control group will receive no treatment for 6 weeks but will answer questionnaires during this time and be offered acupuncture treatment at the end of the 6 week study period. From 25% to 99% of people receiving cancer treatment suffer from fatigue. Preliminary reports suggest that acupuncture may help improve quality of life. The results of this study will be used in the design of a larger trial on the use of acupuncture to support cancer care.
Trial website
Trial related presentations / publications
Smith CA, Carmady B, Thornton C, Perz J, Ussher J. The effect of acupuncture on post cancer fatigue and wellbeing for women recovering from breast cancer: a pilot randomised controlled trial. 2013; 31(1):9-15.
Public notes

Contacts
Principal investigator
Name 30869 0
Prof Caroline Smith
Address 30869 0
NICM, University of Western Sydney
Locked Bag 1797
Penrith
NSW 2751
Country 30869 0
Australia
Phone 30869 0
+61 2 4620 3777
Fax 30869 0
Email 30869 0
[email protected]
Contact person for public queries
Name 14116 0
Prof Caroline Smith
Address 14116 0
Centre for Complementary Medicine Research
LG Building 5 Campbelltown Campus
Locked Bag 1797
Penrith South DC 1797
Country 14116 0
Australia
Phone 14116 0
+61 2 46203777
Fax 14116 0
+61 2 46203291
Email 14116 0
[email protected]
Contact person for scientific queries
Name 5044 0
Prof Caroline Smith
Address 5044 0
Centre for Complementary Medicine Research
LG Building 5 Campbelltown Campus
Locked Bag 1797
Penrith South DC 1797
Country 5044 0
Australia
Phone 5044 0
+61 2 46203777
Fax 5044 0
+61 2 46203291
Email 5044 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

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