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Trial registered on ANZCTR


Registration number
ACTRN12615001152516
Ethics application status
Approved
Date submitted
6/10/2015
Date registered
29/10/2015
Date last updated
21/10/2019
Date data sharing statement initially provided
15/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture to treat cancer related fatigue
Scientific title
Feasibility study: Targeting post cancer fatigue among women and men with breast cancer using acupuncture compared with treatment as usual
Secondary ID [1] 287615 0
None
Universal Trial Number (UTN)
U1111-1175-2675
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer fatigue 296418 0
Health related quality of life 296419 0
Anxiety 296420 0
Depression 296421 0
Condition category
Condition code
Alternative and Complementary Medicine 296685 296685 0 0
Other alternative and complementary medicine
Cancer 296743 296743 0 0
Breast
Mental Health 296744 296744 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A semi-standardised treatment will be administered, this will allow for each participant to have a customized treatment within a standardized theory-driven framework. Participants will receive five points administered at each session (LI4, ST36, REN4, SP6, LI11). Participants will undergo a traditional Chinese medicine (TCM) diagnosis prior to the first treatments session. The diagnosis and treatment will follow an agreed algorithm and will take 60-90 minutes. The diagnosis will guide the customised acupuncture treatment.Additional points may be selected from the following list: SP9, GV14, SiShenCong, Du20, Lu7, Ht6, UB23, UB20, Liv3, P6, GB34, UB62, SI3. This first session will last 60-90 minutes.

The needles will be retained in situ for a minimum of 20 minutes, with the duration of each treatment lasting 45 minutes. Single-use disposable stainless steel Serin needles (0.25 x 40mm and 0.22 x 25mm) will be used. All participants will receive the de qi sensation (a needling sensation of soreness, numbness or heaviness) following initial insertion and once more during treatment. Reinforcing or reducing stimulation will be given according to the TCM diagnoses. Needles will be inserted to depths according to standard texts.

Participants will be offered 10 treatments with treatments commencing week one (one treatment), week two and three (twice weekly), week four to eight (once weekly). Treatment visits will be recorded to monitor adherence to the treatment protocol.

This group receives both acupuncture and treatment as usual.
Intervention code [1] 293006 0
Treatment: Other
Comparator / control treatment
Treatment as usual: is based on a clinical guideline describing the management of CRF This guideline describes education about fatigue, physician and nurse advice during routine consultation on general strategies that help manage fatigue, and advice to initiate and maintain levels of exercise. Existing information brochures from the Cancer Council and NBCF will be made available to participants in this group. Invitation to and voluntary participation in recruiting hospital programmes such as Living Well after Breast Cancer offered by Liverpool Cancer Support Centre will continue as normal for women.
Control group
Active

Outcomes
Primary outcome [1] 296290 0
Severity of CRF assessed using the Fatigue Functional Assessment of Chronic Illness Therapy- Fatigue Scale, and the Structured Clinical Interview for Neurasthenia.
Timepoint [1] 296290 0
Baseline and eight weeks.
Primary outcome [2] 296291 0
Number of women approached to obtain 20 randomisations? Assessed from notes in responses to interest from potential participants and outcomes from screening assessment..
Timepoint [2] 296291 0
8 weeks
Primary outcome [3] 296361 0
Reasons for women not agreeing to participate? Assessed using notes to monitor outcomes from providing information to potential participants.
Timepoint [3] 296361 0
8 weeks
Secondary outcome [1] 318091 0
Health related quality of life measured using the Functional Assessment of Cancer Therapy Breast Cancer,
Timepoint [1] 318091 0
Baseline and eight weeks
Secondary outcome [2] 318239 0
Anxiety and depression measured using the DASS.
Timepoint [2] 318239 0
Assessed at baseline and at 8 weeks
Secondary outcome [3] 318326 0
Numbers meeting eligibility criteria,. Assessed using notes to monitor outcomes from providing information to potential participants.
Timepoint [3] 318326 0
8 weeks.
Secondary outcome [4] 318457 0
Drop out rates, Assessed using notes to monitor outcomes from providing information to potential participants.
Timepoint [4] 318457 0
8 weeks.
Secondary outcome [5] 318458 0
Treatment acceptability. Assessed using notes to monitor outcomes from providing information to potential participants.
Timepoint [5] 318458 0
8 weeks

Eligibility
Key inclusion criteria
1) diagnosis of stage I, II, or III BC, who have completed breast surgery, adjuvant or neo-adjuvant chemotherapy and/or adjuvant radiotherapy between one month to 2 years prior to enrolment and who have not developed recurrent disease in the intervening period between diagnosis and study recruitment.
2) Taking adjuvant endocrine therapy and trastuzumab (Herceptin) are eligible
3) Ongoing cancer related fatigue, defined as a score of 4 or more on the fatigue sub scale of the Somatic and Psychological Health Report (SPHERE) questionnaire
4) Normal coagulation coagulation studies: PT, APTT, INR at baseline or within the previous 1 month.
5) Adequate haematological parameters at baseline or within the previous 1 month: Hb greater than 100, ANC greater than 1.0, Platelet count greater than 150.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Co-morbid medical conditions expected to cause ongoing fatigue, (e.g.co-morbidity significant anaemia (defined as Hb less than 100) or thyroid disease) as assessed by the investigator.
2) Current use of acupuncture.
3) Needle phobia.
4) Concurrent treatment with medication interfering with blood clotting or bleeding time, including heparin and fractionated heparin, vitamin K antagonists, direct thrombin inhibiitors, factor Xa inhibitors, and antiplatelet agents.
5) Life expectancy less than six months.
6) Plan for major surgery during the time of the study e.g. breast reconstruction or re-excision.
7) History of other malignany within 5 years of recruitment, other than CIN of cervix or non-melanomatous skin cancers.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To carefully measure the effect of acupuncture in a small sample, and test the safety, feasibility and acceptability of acupuncture for management of CRF we will undertake descriptive analysis to summarise the process data describing the feasibility of the study.

A sample size of 20 has been selected to address the study questions. A power analysis and sample size calculation has not been undertaken.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/11/2015
Actual
26/11/2015
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4434 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 12410 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 10639 0
2200 - Bankstown
Recruitment postcode(s) [2] 24683 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 292176 0
Hospital
Name [1] 292176 0
Clinical Cancer Research Unit, Bankstown-Lidcombe Hospital
Country [1] 292176 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country
Australia
Secondary sponsor category [1] 290849 0
None
Name [1] 290849 0
NA
Address [1] 290849 0
NA
Country [1] 290849 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293649 0
South West Sydney LHD
Ethics committee address [1] 293649 0
Ethics committee country [1] 293649 0
Australia
Date submitted for ethics approval [1] 293649 0
21/05/2015
Approval date [1] 293649 0
20/07/2015
Ethics approval number [1] 293649 0
15/224
Ethics committee name [2] 293650 0
University of Western Sydney
Ethics committee address [2] 293650 0
Ethics committee country [2] 293650 0
Australia
Date submitted for ethics approval [2] 293650 0
09/08/2015
Approval date [2] 293650 0
09/09/2015
Ethics approval number [2] 293650 0
H11297

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60826 0
Prof Caroline Smith
Address 60826 0
National Institute of Complementary Medicine
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 60826 0
Australia
Phone 60826 0
+61 2 46203777
Fax 60826 0
Email 60826 0
[email protected]
Contact person for public queries
Name 60827 0
Caroline Smith
Address 60827 0
National Institute of Complementary Medicine
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 60827 0
Australia
Phone 60827 0
+61 2 46203777
Fax 60827 0
Email 60827 0
[email protected]
Contact person for scientific queries
Name 60828 0
Caroline Smith
Address 60828 0
National Institute of Complementary Medicine
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
Country 60828 0
Australia
Phone 60828 0
+61 2 46203777
Fax 60828 0
Email 60828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No current ethics approval


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.