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Trial registered on ANZCTR


Registration number
ACTRN12622000081718
Ethics application status
Approved
Date submitted
21/12/2021
Date registered
21/01/2022
Date last updated
27/10/2023
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Electroacupuncture for taxane-induced peripheral neuropathy in patients with Breast Cancer during treatment
Scientific title
Pilot feasibility randomised sham-controlled trial of electroacupuncture for taxane-induced peripheral neuropathy in Breast Cancer patients during treatment
Secondary ID [1] 306087 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chemotherapy-induced peripheral neuropathy 324747 0
Condition category
Condition code
Cancer 322199 322199 0 0
Breast
Neurological 322297 322297 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention consists of electroacupuncture (EA) administered once a week over ten weeks, with a total of 10 treatments for each participant. The participants will receive EA at the following locations: upper limb - LI4, TE6, Baxie (M-UE-22) and lower limb - ST36, LR3, bafeng (M-LE-8). The needles in the webs of the toes and fingers will be inserted to the depth of between 5 to 10mm at (Baxie and Bafeng acupoints) and 10 – 13mm at the remaining acupoints. Single-use disposable stainless steel Dongbang needles (0.20 x 15mm) will be used. Leads from the EA machine (ITO Co Ltd, 143609 Acuneeds Australia Pty LtD – stimulator, electrical, acupuncture) will be placed on the points Baxie and Bafeng. The electrostimulation will be delivered at a low frequency (2 Hz), on a disperse continuous setting, with moderate intensity. Duration of each treatment will be 45 minutes where the intervention will be administered by a registered acupuncturist with oncology experience. The timing of intervention administration will be timed +/- 2 days pre-infusion (weekly), this will usually be the same day as routine blood test prior to infusion. Adherence to the intervention will be monitored with a session attendance checklist, which will also be checked weekly.
Intervention code [1] 322496 0
Treatment: Devices
Comparator / control treatment
The frequency and duration of the intervention will be the same as the active EA group. The participants will receive sham-EA at the same acupoints as the active group. The sham-acupuncture will be a non-penetrative method where a specialised device called a ‘Streitberger needle’ will be used to elicit a similar sensation only on the surface of the skin. Leads from the EA device will be attached to the sham device at prescribed acupoints with no electrostimulation administered. To allow the treatment to appear realistic the machine will be turned on, the machine will sound a beeping noise while switched on, however the leads will be connected to a terminal without stimulation. The sham-EA will be applied over true acupoints without manual or electrical stimulation.
Control group
Placebo

Outcomes
Primary outcome [1] 329965 0
Recruitment rate - the number of participants recruited per month assessed by audit of study records
Timepoint [1] 329965 0
At the conclusion of study
Primary outcome [2] 329966 0
Adherence rate - Proportion of participants who complete 7 out of 10 planned study treatments
Timepoint [2] 329966 0
At the conclusion of study
Primary outcome [3] 329967 0
Successful blinding of participants - Proportion of participants who correctly identify intervention received (i.e., EA or sham-EA) at final (10th) treatment assessed by study-specific questionnaire
Timepoint [3] 329967 0
After the final (10th) treatment
Secondary outcome [1] 404472 0
Change in CIPN symptoms as measured by summary scores of EORTC QLQ-CIPN20 - From randomisation to end of week 12 of paclitaxel treatment
Timepoint [1] 404472 0
Weekly measures, at randomisation to end of week 12 of paclitaxel treatment
Secondary outcome [2] 404473 0
Sustained change in CIPN symptoms as measured by summary scores of EORTC QLQ-CIPN20
Timepoint [2] 404473 0
Measured at 8 weeks and 24 weeks follow up after completion of 12th paclitaxel treatment
Secondary outcome [3] 404474 0
The number of CIPN related dose modifications or treatment delays - based on patient electronic medical records
Timepoint [3] 404474 0
At time of final taxane treatment (12th paclitaxel treatment)
Secondary outcome [4] 428286 0
Change in acupuncture response expectancy (Acupuncture Expectancy Scale)
Timepoint [4] 428286 0
Secondary outcome [5] 428287 0
Change in acupuncture response expectancy (Acupuncture Expectancy Scale)
Timepoint [5] 428287 0
Before 1st, at 5th (midpoint) and 10th (end) intervention session
Secondary outcome [6] 428288 0
Safety assessment - proportion of participants with unexpected EA related adverse events (e.g., bruising, bleeding, localised pain or discomfort)
Timepoint [6] 428288 0
Before 1st, at 5th (midpoint) and 10th (end) intervention session
Secondary outcome [7] 428289 0
Safety assessment - proportion of participants with unexpected EA related adverse events (e.g., bruising, bleeding, localised pain or discomfort)
Timepoint [7] 428289 0
Any point during the intervention, assessed by self-reported
Secondary outcome [8] 428290 0
Primary outcome 4: Compliance with follow up
Timepoint [8] 428290 0
Any point during the intervention, assessed by self-reported
Secondary outcome [9] 428291 0
Primary outcome 4: Compliance with follow up
Timepoint [9] 428291 0
8 weeks and 24 weeks post-chemotherapy

Eligibility
Key inclusion criteria
1. Age - greater than or equal to 18 years old
2. Stage I-III breast cancer.
3. Scheduled to receive weekly adjuvant or neoadjuvant paclitaxel treatments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior use of acupuncture for CIPN on more than one occasion within 6 months prior to commencement of the study.
2. Peripheral neuropathy due to a pre-existing condition prior to chemotherapy (e.g., including alcoholism, diabetic, congenital neuropathy, toxic neuropathy, nerve compression or injury, neuroma).
3. Presentation of autonomic related CIPN symptoms

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)
Allocation sequence and participant assignment to the intervention will be completed by the biostatistician. Allocation concealment will be achieved via opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be assigned to either EA or sham-EA group with a 1:1 allocation rate as per computer-generated randomisation scheduled using random permuted block sizes. The study participants will be blinded to group allocation until the end of the study after the final assessments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size estimation:
As this is a phase II pilot study, the sample size calculation was based on the detection of an effect size of 0.8 (“large effect size”) in any of the continuous measures. The results obtained from this study will inform targeted sample size calculations in a future prospective trial. Using a two-sample t-test and assuming equal numbers in EA and sham-EA groups, and equal variances in the groups, a total of 40 participants (20 per treatment arm) will provide 80% power at a two-sided significance level of 5%, allowing 20% drop-out rate, to detect a “large” change in a continuous outcome measure.

Statistical analysis plan:
• The statistical analysis will be performed by a qualified biostatistician who will be blinded to the group allocation. Subjects will be analysed according to the intention to treat principle.
• Demographic characteristics and baseline scores summarised as mean (SD) for continuous variables or medians (quartiles) if the distribution is skewed. Counts with percentages will be presented for categorical variables.
• The primary endpoints will be summarised as counts (percentages) (i.e., recruitment rate, adherence rate, successful blinding of participants, compliance with follow up) or means (standard deviations) (i.e., patient overall satisfaction of intervention and practitioner overall satisfaction), by treatment group.
• Secondary outcomes will be summarised as mean (SD) by treatment group at each time point of interest. Generalised estimating equations (GEE) will be used to assess the effect of treatment over time.
• The main CIPN assessment will be the change in EORTC QLQ-CIPN20 score from baseline to end of treatment (t10). The mean change in each treatment group will be summarised as mean (SD) and compared using a nonparametric test (Mann-Whitney). Covariables of interest will include age, gender and BMI. Results will be presented with 95% confidence intervals and p-value. No interim analysis will be carried out for this study.
• The primary analysis will be on a complete case basis. If there are missing data values, multiple imputation will be used to provide a sensitivity analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
2/06/2022
Date of last participant enrolment
Anticipated
22/12/2023
Actual
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
40
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21391 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 36280 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 310430 0
Hospital
Name [1] 310430 0
Chris O'Brien Lifehouse
Country [1] 310430 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse Surfebruary Cancer Research Fund
Address
119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 311667 0
None
Name [1] 311667 0
Address [1] 311667 0
Country [1] 311667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310067 0
St Vincent's Hospital HREC
Ethics committee address [1] 310067 0
Ethics committee country [1] 310067 0
Australia
Date submitted for ethics approval [1] 310067 0
15/11/2021
Approval date [1] 310067 0
22/12/2021
Ethics approval number [1] 310067 0
2021/ETH12123

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

Contacts
Principal investigator
Name 116378 0
Dr Victoria Choi
Address 116378 0
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050
Country 116378 0
Australia
Phone 116378 0
+61 466 807 734
Fax 116378 0
Email 116378 0
victoria.choi@lh.org.au
Contact person for public queries
Name 116379 0
Victoria Choi
Address 116379 0
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050
Country 116379 0
Australia
Phone 116379 0
+61 2 8514 0386
Fax 116379 0
Email 116379 0
victoria.choi@lh.org.au
Contact person for scientific queries
Name 116380 0
Victoria Choi
Address 116380 0
Chris O'Brien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050
Country 116380 0
Australia
Phone 116380 0
+61 2 8514 0386
Fax 116380 0
Email 116380 0
victoria.choi@lh.org.au

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


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
SourceTitleYear of PublicationDOI
EmbaseElectroacupuncture use for treatment of taxane-induced peripheral neuropathy in patients with breast cancer: Protocol for a pilot, randomised, blinded, sham-controlled trial (EA for CIPN).2024https://dx.doi.org/10.1136/bmjopen-2023-076391
N.B. These documents automatically identified may not have been verified by the study sponsor.