Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000303448
Ethics application status
Approved
Date submitted
5/07/2024
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study of acupuncture for pain in advanced cancer (Cancer PAIN Trial)
Scientific title
An Open Label Single-arm Feasibility Study of Acupuncture for Pain in Patients with Advanced Cancer
Secondary ID [1] 311618 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Cancer PAIN Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advanced cancer 333098 0
pain 334311 0
Condition category
Condition code
Alternative and Complementary Medicine 330965 330965 0 0
Other alternative and complementary medicine
Cancer 330966 330966 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Pilot open label single-arm trial assessing the feasibility of performing acupuncture for cancer pain. Participants will receive twice-weekly acupuncture sessions (for 30 minutes) over 4 weeks. 8 sessions of acupuncture in total.
The study intervention will be based on acupuncture points commonly used for cancer pain18 and provided by clinicians with Australian Health Practitioners Regulation Agency (AHPRA) accreditation to perform acupuncture, and with >50 hours experience.

The intervention involves locating each point of interest, tapping in the needle, removing the guide tube and manipulating the needle. Sterile single-use needles will be used. The intervention will take 30 minutes.

Acupuncture treatment will be conducted using a semi-standardised method, which reflects both practice in usual care and in reported acupuncture trials. This involves delivering the acupuncture to 5 consensus standardised points used for cancer pain (Hegu (LI4), Taichong (LR3), Zusanli (ST36), Sanyinjiao (SP6), Yanglingquan (GB34)) bilaterally. Up to 5 additional points are able to be chosen to tailor treatment to location of pain.

Strategies used to monitor adherence include usual-care documentation of intervention post-session and completion of attendance form.
Intervention code [1] 328988 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338733 0
Feasibility
Timepoint [1] 338733 0
Baseline, twice-weekly until completion of acupuncture intervention (4 weeks post-baseline)
Primary outcome [2] 340959 0
Completion rates of acupuncture intervention treatments
Timepoint [2] 340959 0
Baseline, twice-weekly until completion of acupuncture intervention (4 weeks post-baseline)
Primary outcome [3] 340960 0
Completion rates of trial assessments
Timepoint [3] 340960 0
Baseline, twice-weekly until completion of acupuncture intervention (4 weeks post-baseline)
Secondary outcome [1] 437239 0
Pain
Timepoint [1] 437239 0
Baseline, twice-weekly until completion of acupuncture intervention (4 weeks post-baseline)
Secondary outcome [2] 445605 0
Qualitative subsidy evaluating acceptability, burden, participant experience, reasons for discontinuation (if any) and barriers/ enablers to future roll-out of phase III study
Timepoint [2] 445605 0
Qualitative interviews will be conducted within 2 days of the End of Treatment assessment

Eligibility
Key inclusion criteria
A. Age 18 years or older
B. Advanced cancer (histological or clinical diagnosis) defined by intent of treatment no longer being curative
C. Experiencing pain related to the cancer
D. Brief Pain Inventory-Short Form average pain score equal to or greater than 4 in the previous 24 hours
E. Capable of completing assessments and complying with the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A. Participant currently or within 4 weeks of receiving acupuncture
B. Clinician predicted survival less than 8 weeks
C. Participant planned to receive radiotherapy to a site of pain during the acupuncture treatment study period, or who have received radiotherapy to a site of pain within 2 weeks before study entry
D. Participants commencing a new line of chemotherapy, hormone therapy, immunotherapy or targeted therapy within 2 weeks prior to study entry
E. Participant with cellulitis, lymphoedema or disruption to skin integrity in the acupuncture treatment region
F. Participant with cutaneous/ subcutaneous malignancy at site of treatment
G. Participant with moderate or severe thrombocytopenia (platelet count <50 x109/L)
H. Patients requiring more than 6 doses of breakthrough immediate release opioid per day

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26762 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 42811 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 315926 0
Charities/Societies/Foundations
Name [1] 315926 0
Bethlehem Griffith Research Foundation
Country [1] 315926 0
Australia
Primary sponsor type
University
Name
Cancer Symptom Trials at University of Technology, Sydney
Address
Country
Australia
Secondary sponsor category [1] 319133 0
None
Name [1] 319133 0
Address [1] 319133 0
Country [1] 319133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314774 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 314774 0
Ethics committee country [1] 314774 0
Australia
Date submitted for ethics approval [1] 314774 0
22/03/2024
Approval date [1] 314774 0
24/04/2024
Ethics approval number [1] 314774 0

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

Contacts
Principal investigator
Name 132682 0
Dr Lucy Demediuk
Address 132682 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
Country 132682 0
Australia
Phone 132682 0
+61403210478
Fax 132682 0
Email 132682 0
[email protected]
Contact person for public queries
Name 132683 0
Lucy Demediuk
Address 132683 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
Country 132683 0
Australia
Phone 132683 0
+61 3 8559 5000
Fax 132683 0
Email 132683 0
[email protected]
Contact person for scientific queries
Name 132684 0
Lucy Demediuk
Address 132684 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC, 3000
Country 132684 0
Australia
Phone 132684 0
+61 3 8559 5000
Fax 132684 0
Email 132684 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.