Trial Review

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
Help: Registration number
ACTRN12626000671369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/03/2026
Date registered
Help: Date registered
5/06/2026
Date last updated
Help: Date last updated
5/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
5/06/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy (CIPN) in patients with early-stage colorectal cancer: A Feasibility, Effectiveness, and Safety Study
Scientific title
Acupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy (CIPN) in patients with early-stage colorectal cancer: A Feasibility, Effectiveness, and Safety Study
Additional trial identifiers [1] 316901 0
‘Nil known
Universal Trial Number (UTN)
U1111-1338-1473
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Chemotherapy-Induced Peripheral Neuropathy (CIPN) 341316 0
Condition category
Condition code
Alternative and Complementary Medicine 337388 337388 0 0
Other alternative and complementary medicine
Cancer 337389 337389 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Neurological 337390 337390 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The project will design randomized clinical trial at Northern Health Hospital in Melbourne. Participants are diagnosed as early stage colorectal cancer. Participants are over 18 years old and plan to receive chemotherapy ( mFOLFOX) that may cause CIPN.

The study will conduct a randomized controlled trial with two arms: acupuncture group (15 participants) and controlled group without acupuncture (15 participants) at 1:1 Ratio. Acupuncture groups have one acupuncture treatment weekly for 24 weeks. After 24 weeks, acupuncture will be voluntary to continue acupuncture treatment until week 36. The controlled group does not have acupuncture treatment for an initial 24 weeks, only undergoing assessment and testing. After 24 weeks, the controlled group can voluntarily begin acupuncture treatment for three months.

15 participants of 30 participants and 6 health practitioners will be invited to be interviewed for sub-study face to face/online.

Acupuncturist: AHPRA-registered acupuncturist with more than 5 years’ experience with professional indemnity insurance. The acupuncturist will gently insert very fine needles into certain areas of your body following the protocol.
Duration of the acupuncture sessions:
• The needles typically stay in place for 20 to 30 minutes while the patient rests quietly. It is expected that each acupuncture treatment will take approximately 45 minutes to 1 hour. Treatments are done in a clean, comfortable setting, and all needles are single-use and disposable for your safety.
What is involved during the acupuncture treatment:
• Acupuncture treatment may involve either manual or electro acupuncture. The acupuncturist will assess each participant’s health condition to determine whether manual or electro acupuncture is most suitable. Based on this assessment, patients can choose their preferred approach (manual or electro), which will remain consistent throughout the whole trial unless there is a change in their condition.

Electroacupuncture is a therapeutic technique in which a gentle electrical current (maximum output of 32 mA) is delivered through acupuncture needles using a medical device. In this study, the Acupuncture Stimulator (ES160) will be used, this device is an approved medical therapeutic device in Australia and is listed under entry 13763 (Stimulator) on the Australian Register of Therapeutic Goods (ARTG). Electroacupuncture has an established safety record and has been used in clinical practice for many years.

Strategies used to assess or monitor adherence to the intervention:
Metric tools:
1. Patient Neurotoxicity Questionnaire (PNQ).
2. Functional Assessment of Cancer Therapy—Neurotoxicity subscale (FACT- NTX).
3. Neuropathic pain assessment (LANSS).
4. Quantitative sensory testing (QST).

How participants for the sub-study will be selected:
15 trial patients of 30 patients and 6 Health practitioners are interviewed (online or in-person) for sub-study.


Sub-interview study:

The sub-interview study will assess participants’ comfort and satisfaction throughout the entire study to evaluate the feasibility of acupuncture as a preventative approach for CIPN.

The sub- interviews can be conducted face-to-face at Northern Health Hospital or RMIT University in Bundoora, or via online. Each interview will take approximately 20 to 30 minutes. Member of the research team in the project will interview participants.

The Participants in sub-interview study will be required to attend a total of two interviews and complete one questionnaire form: the first interview during the enrolment, a second questionnaire will be filled out at week 13 (the midpoint of the study), and a final interview will take place at week 28 (the end of the study).

Interview data will be digitally recorded including audio/video record. Participants' names will be coded to ensure confidentiality, and a summary of each interview will be sent to the participants for final confirmation.

When the intervention occurs relative to chemotherapy treatment:

Patients will receive one acupuncture session per week for 24 weeks (a total of 24 sessions). Acupuncture will be scheduled one day before each chemotherapy session. This is also the day patients usually have your blood test, so both can be done on the same day. The following week, acupuncture appointment will be on the same day as the previous week of acupuncture day.

Example: If patient chemotherapy starts on a Wednesday (Cycle 1-day1), first acupuncture session will be on Tuesday that is blood test day, which helps patient reduces the travel burden. The following week, the acupuncture session will again be on Tuesday.
Intervention code [1] 333609 0
Prevention
Intervention code [2] 333879 0
Treatment: Other
Description of the comparator or control
Controlled group is without acupuncture (15 participants).The controlled group does not have acupuncture treatment for an initial 24 weeks, only undergoing assessment and testing. After 24 weeks, the controlled group can voluntarily begin acupuncture treatment for three months.
Control group
Active

Outcomes
Primary outcome [1] 344906 0
Feasibility of Acupuncture for Preventing CIPN (objective 1)
Timepoint [1] 344906 0
Recruitment rate : timepoint -End of month 1, End of month 2, End of month 3 over three months of recruitment, assessment method through log form/screening form/ PICF form. Application Completion rate: timepoint -End of month 1, End of month 2, End of month 3 over three months ,assessment method through log form/ PICF form.
Primary outcome [2] 344907 0
Effectiveness of acupuncture preventing CIPN (objective 2)
Timepoint [2] 344907 0
From baseline, during chemotherapy at the cycle 3, 5, 7,9,11 and the last cycle and 4-12 weeks after the last chemotherapy. (week1,5,9,13,17,21,24,28.)
Primary outcome [3] 345209 0
Effectiveness of acupuncture preventing CIPN (objective 2)
Timepoint [3] 345209 0
Baseline, week 9,17, last cycle.
Secondary outcome [1] 459723 0
Safety of acupuncture for preventing CIPN (objective 3)
Timepoint [1] 459723 0
During /after acupuncture treatment / each session
Secondary outcome [2] 459726 0
Understand the experience and opinions of cancer participants(patients) and Healthcare practitioners (objective 4)
Timepoint [2] 459726 0
The first interview during the enrolment, a second questionnaire will be filled out at week 13 (the midpoint of the study), and a final interview will take place at week 28 (the end of the study).
Secondary outcome [3] 461436 0
Feasibility of Acupuncture for Preventing CIPN (objective 1)-Primary Outcome
Timepoint [3] 461436 0
Timepoint: baseline/enrollment, week 24.
Secondary outcome [4] 461437 0
Feasibility of Acupuncture for Preventing CIPN (objective 1)-Primary Outcome
Timepoint [4] 461437 0
Timepoint: baseline/enrollment,12-17 week.
Secondary outcome [5] 461438 0
Feasibility of Acupuncture for Preventing CIPN (objective 1)-Primary Outcome
Timepoint [5] 461438 0
Timepoint: baseline/enrollment, day of withdrawing in the study
Secondary outcome [6] 461439 0
Feasibility of Acupuncture for Preventing CIPN (objective 1)-Primary Outcome
Timepoint [6] 461439 0
Timepoint :baseline/enrollment, day of withdrawing due to AE in the study,
Secondary outcome [7] 461937 0
Effectiveness of acupuncture preventing CIPN (objective 2)- Primary Outcome
Timepoint [7] 461937 0
From baseline, during chemotherapy at the cycle 3, 5, 7,9,11 and the last cycle and 4-12 weeks after the last chemotherapy. (week1,5,9,13,17,21,24,28.)
Secondary outcome [8] 461938 0
Effectiveness of acupuncture preventing CIPN (objective 2) -Primary Outcome
Timepoint [8] 461938 0
From baseline, during chemotherapy at the cycle 3, 5, 7,9,11 and the last cycle and 4-12 weeks after the last chemotherapy. (week1,5,9,13,17,21,24,28.)

Eligibility
Key inclusion criteria
Eligibility criteria:
Patients from the hospital (Northern Health Hospital): Patients diagnosed with early-stage colorectal cancer who have undergone surgical intervention for the removal of their colon cancer, plan to receive adjuvant chemotherapy based on oxaliplatin. This treatment is administered through a regimen known as modified FOLFOX-6 (mFOLFOX-6).

Inclusion Criteria:
1. Patients must be over 18 years old.
2. Patients are referred by oncologists to the trial at Northern Health Hospital.
3. Patients must be willing to commit to the clinical trial and stay in the trial for a duration
of 24-36 weeks. They are required to sign the Participant Information and Consent Form
(PICF), Which outlines the project details, including each treatment session lasting 30-45
minutes and involving manual acupuncture / electroacupuncture. Patients agree to
receive documentation digitally, delivered by email or post.
4. Patients need to provide informed consent in English and complete study questionnaires
in English.
5. Patients may have a medical history of diabetes but must not have peripheral neuropathy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion Criteria:
1.Patients are currently receiving chemotherapy or radiotherapy or have undergone
tumor resection surgery in the past month.
2.Patients who have received chemotherapy with neuropathic agents like vinca
alkaloids, bortezomib, or thalidomide in the past six months.
3. Local infection at or near the acupuncture site renders the patient unsuitable for
acupuncture, as determined by a physician/ acupuncturist. Other factors, such as
needle phobia, may also preclude a patient from receiving acupuncture treatment.
4.Patients use other alternative medicines such as herbal agents or high dose vitamins
and minerals, as determined by a study doctor.
5.Patients have a low platelet count (below 50,000/µL) or low white blood cell count
(below 3,000/µL) when screening participants.
6.The patients have active central nervous system (CNS) diseases such as multiple
sclerosis.
7.The patients have severe heart disease/epilepsy.
8.Any patients have psychological or behavioral disorders, as determined by a study
doctor.
9.The patients have previous acupuncture treatment for any indication before 30 days
of enrolment.
10.The patient takes current medications that could affect symptoms related to CIPN.
11.Grade III lymphedema or more severe situations, such as systemic oedema arising
from cardiogenic or nephrogenic disease.
12.Patients have pre-existing peripheral neuropathy.
13.Patients are allergic to nickel.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will conduct a randomized Controlled Trial with two arms: acupuncture group (15 participants) and controlled group without acupuncture (15 participants) at 1:1 Ratio with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification factors are typically based on variables known to influence the outcome including demographic factors: age, sex/gender, race/ethnicity; cancer stage; prior treatment history; risk factors: smoking status.
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
1/07/2026
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 321496 0
University
Name [1] 321496 0
RMIT University
Country [1] 321496 0
Australia
Funding source category [2] 321497 0
Commercial sector/Industry
Name [2] 321497 0
Acuneeds company support Acupuncture needles.
Country [2] 321497 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 324254 0
Other Collaborative groups
Name [1] 324254 0
Northern Health
Address [1] 324254 0
Country [1] 324254 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320030 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 320030 0
Ethics committee country [1] 320030 0
Australia
Date submitted for ethics approval [1] 320030 0
06/05/2025
Approval date [1] 320030 0
06/01/2026
Ethics approval number [1] 320030 0

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

Contacts
Principal investigator
Name 149198 0
Dr George Lenon
Address 149198 0
225 Plenty Road, Bundoora West, VIC, 3083, Australia. RMIT University
Country 149198 0
Australia
Phone 149198 0
+610400821631
Fax 149198 0
Email 149198 0
[email protected]
Contact person for public queries
Name 149199 0
Hang Liu
Address 149199 0
225 Plenty Road, Bundoora West, VIC, 3083, Australia. RMIT University
Country 149199 0
Australia
Phone 149199 0
+61 0452580609
Fax 149199 0
Email 149199 0
[email protected]
Contact person for scientific queries
Name 149200 0
Hang Liu
Address 149200 0
225 Plenty Road, Bundoora West, VIC, 3083, Australia. RMIT University
Country 149200 0
Australia
Phone 149200 0
+61 0452580609
Fax 149200 0
Email 149200 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form  [email protected]


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.