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Trial registered on ANZCTR


Registration number
ACTRN12620000325909
Ethics application status
Approved
Date submitted
11/02/2020
Date registered
9/03/2020
Date last updated
9/03/2020
Date data sharing statement initially provided
9/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture for Cancer Related Pain
Scientific title
Acupuncture for Cancer Related Pain: A pragmatic randomised-controlled trial
Secondary ID [1] 300471 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer related pain 316140 0
Condition category
Condition code
Cancer 314430 314430 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME
Acupuncture

WHY
Acupuncture has been widely used for many conditions including pain. In China, in which use of acupuncture originated, it has been widely used for cancer treatment for many years. It is now recommended in the National Comprehensive Cancer Network (NCCN) guidelines for cancer pain in adults as part of integrative interventions in the United States. Acupuncture is also recommended by the American Society of Clinical Oncology (ASCO) practice guidelines specifically for chronic pain in cancer survivors.
Implementation of acupuncture within hospitals as a prominent therapy offered as part of integrative oncology programs is an increasing trend in cancer care in developed Western countries worldwide. In a 2013 European survey of integrative oncology, acupuncture (55%) was most commonly provided in integrative oncology centres in Europe for supportive care.
In the USA, acupuncture is a standard therapy commonly offered as part of integrative oncology programs in major hospitals alongside conventional medicine. A recent systematic review has found that in the United States, more than 80% of National Cancer Institute (NCI) designated cancer centres governed by the National Institute of Health (NIH) recommend acupuncture for symptom management and a majority (73%) provide acupuncture as part of integrative oncology programs to treat a variety of symptoms and conditions associated with cancer and the side effects of cancer treatments. Leading NCI designated cancer centres, including Dana-Farber Cancer Institute (DFCI), the premier academic medical and research hospital of Harvard Medical School in Boston, Memorial Sloan- Kettering Cancer Centre in New York, and M.D. Anderson Cancer Centre in Houston, have nearly 20 years of history in developing and implementing clinical models of acupuncture within integrative oncology programs to address patients’ unmet needs.

WHAT
Acupuncture is a Chinese medicine therapy that involves the use of needles inserted into specific points on the skin. There are several different forms of acupuncture, including traditional body acupuncture, electroacupuncture, microsystem acupuncture (such as auricular acupuncture and scalp acupuncture), acupressure and moxibustion.
Based on Chinese Medicine theories and clinical evidence, 4 points in the limbs and several points in the back will be selected for acupuncture.
The auricular acupressure, which involves pressing ear seeds against auricular points,will used to ensure prolonged effects of pain management. The auricular points are all located on the ear.
The participant will be asked to lie down on a massage table with the needling area exposed. The body acupuncture points will be punctured with 0.25*40 mm stainless steel, single used needles manufactured by Helio USA (https://www.heliousa.com/products/acupuncture-needles.html). Insertion technique will be one-hand insertion method. Lifting and twisting techniques will be used for each points until the participant can feel the needling sensation commonly known as “deqi”, with a series of soreness, numbness, distention or heaviness around the needle site. The needles will be retained for 30 min without manipulation. After the body acupuncture, ear seeds manufactured by Earseed USA (https://www.earseeds.com/shop-by-condition-2/) will be applied to the auricular acupuncture points and pressed until the pressure sites reacted with hot sensation. The pressure seeds sit on a sticky bandage and will be remain on the ear for 3 days. The participant will be asked to massage the pressure seeds three time a day as directed in the protocol.

WHO PROVIDED
Acupuncture will be given by Dr Qi Zhao, who came from a family of traditional Chinese medicine and was influenced by it from a young age. He was majored in acupuncture and massage therapy at Beijing University of Chinese Medicine and also received a Doctor degree of medicine. He has been working in the field for over 17 years and is skilful at treating diseases through acupuncture and herbs. Dr Zhao is experienced in treating some of the common conditions including cervical spondylosis, protrusion of lumbar intervertebral discs, lumbar muscle strain, shoulder stiffness, knee pain, ischialgia, headache, sequela of stroke, rheumatoid arthritis, insomnia, herpes zoster, allergic disorders, depression, acne, eczema and chronic gastritis. The researcher has over 17 years of clinical experiences in treatment using Acupuncture, in Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine. He has previously conducted clinical in Beijing investigating the effects of Acupuncture in pain related conditions. The researcher has a PhD degree in clinical medicine, and a master degree in clinical science with Acupuncture and Tuina (Chinese Massage Therapy), also a Bachelor degree in Medicine and Chinese Medicine. All degree were obtained in China under Beijing University of Chinese Medicine.

HOW
Acupuncture will be delivered face to face individually.

WHERE
The intervention will be given in Liverpool Hospital, the leading hospital in the South Western Sydney Local Health District (SWSLHD). The hospital has provided a fully comprehensive range of cancer services since 1995. There has been a strong trend for integrating allied health services for improving cancer survivorship. The construction of a facility, Oncology Alliance for the Science of Integrative Survivorship (OASIS) is supported by the Australian Cancer Research Foundation (ACRF) since 2017. The facility is located at the Wellness Centre at the hospital, annual visits were 1,098 in 2017 with 11,138 occasions of services provided by allied health staff. Acupuncture is one of the most popular services at the Centre.

WHEN and HOW MUCH
This study is a pragmatic randomised controlled trial with two groups, an intervention group (acupuncture plus standard analgesic medication) and a control group in a setting as wait-list (standard analgesic medication). The participants are randomly assigned into the two groups by computer with a 1:1 allocation ratio.
Intervention group: a total of 8-week will be involved which includes 4-week acupuncture intervention and 4-week follow-up. Participants will receive a 40-minutes acupuncture intervention twice per week over 4 weeks in addition to continuing their prescribed analgesic medication for CRP. On completion of the final intervention, participants will complete a 4-week follow-up, during which they will continue to take their prescribed analgesic medication for CRP.
Control group: a total of 12-week will be involved which includes 4-week on wait-list, 4-week on acupuncture and 4-week follow-up.From week-1 to week-4, participants will wait to receive the intervention whilst continuing prescribed analgesic medication for CRP. From week-5 to week-8 participants will receive a 40-minutes acupuncture intervention twice per week for a total of eight interventions over 4 weeks in addition to continuing their prescribed analgesic medication for CRP. On completion of the final intervention, participants will complete a 4-week follow-up, during which they will continue to take their prescribed analgesic medication for CRP.
During each intervention session, each participant will also be asked questions about the pain, medication and side effects, which will take around 5 minutes. During the first and the eighth intervention session, each participant will be asked to complete a survey, which will take around 10 minutes. During the last session, participants will not receive an intervention but report pain level and analgesic use, which will take around 5 minutes.

TAILORING
The points used will include body acupuncture points and auricular points, both of which were planned to be personalised during each session. According to Traditional Chinese Medicine theory, back-shu points and auricular points will be selected by cancer type and pain location. The customized point selection will be done by Dr Qi Zhao based on the Traditional Chinese Medicine theories.

MODIFICATIONS
N/A

HOW WELL
Each eligible participant will receive a timetable for the study. A message will be sent to the participant as a reminder of each coming session. The principal investigator will explain why and how to massage the sear seeds. Timed messages will work as the reminders of massaging the ear seeds three times a day. The participants are encouraged to contact the research assistant or the principal investigator to ask questions relevant with the trial.
Intervention code [1] 316769 0
Treatment: Other
Comparator / control treatment
wait list control (4-weeks-wait before intervention)
Control group
Active

Outcomes
Primary outcome [1] 322771 0
Pain level measured by Numerical Rating Scale (NRS) and Visual Analogue Scale (VAS)
Timepoint [1] 322771 0
For intervention group: 1) twice a week for 4 weeks post-enrolment; 2) a follow-up 4 weeks post-intervention.
For control group: 1) twice a week for 4 weeks post-wait; 2) a follow-up 4 weeks post-intervention.
Secondary outcome [1] 379679 0
Analgesic use (Name and dosage) verbally reported by the participant.
Timepoint [1] 379679 0
For intervention group: 1) once a week for 4 weeks post-enrolment; 2) a follow-up 4 weeks post-intervention.
For control group: 1) once a week for 4 weeks post-wait; 2) a follow-up 4 weeks post-intervention.
Secondary outcome [2] 379680 0
Safety - assessing the severity of the adverse events by both the research team and hospital clinicians.
The known adverse events of acupuncture are:
• Bleeding or haematoma (occurs in 3 on 100 cases)
• Needling pain (occurs in 1 on 100 cases)
• Aggravation (occurs in 1 on 100 cases)
• Faintness (occurs in 3 on 1000 cases)
• Drowsiness after treatment (occurs in 3 on 1000 cases)
• Stuck or bent needle (occurs in 1 on 1000 cases)
• Headache (occurs in 1 on 1000 cases)
Timepoint [2] 379680 0
For intervention group: Adverse events will be recorded twice a week for 4 weeks post-enrolment.
For control group: 1) Adverse events will be recorded twice a week for 4 weeks post-wait.
For all eligible participants: Regular meetings will be scheduled by the primary investigator to discuss the adverse events with hospital clinicians.

Eligibility
Key inclusion criteria
• Age 18 years old or older.
• A diagnostic certificate of CRP provided by an oncologist of Liverpool hospital, regardless of the cancer type, stage or the presence of metastasis.
• Included types of pain: somatic nociceptive pain, visceral nociceptive pain, neuropathic pain and mixed types of pain.
• Numerical Rating Scale (NRS) score > 3.
• Cognitive ability to give consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Presence of skin infection that potentially interferes with the needling (intervention) area.
• Presence of thrombocytopenia, fever or active infection.
• Inability to remain supine position for 40 minutes continuously, given the nature of the acupuncture intervention.
• Estimated survival time less than or equal to 12 weeks.
• Numerical Rating Scale (NRS) score less than or equal to 3.
• Pregnant woman.

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)
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304886 0
University
Name [1] 304886 0
Western Sydney University
Address [1] 304886 0
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country [1] 304886 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country
Australia
Secondary sponsor category [1] 305232 0
None
Name [1] 305232 0
Address [1] 305232 0
Country [1] 305232 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305301 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305301 0
Research Directorate, Locked Bag 7103, LIVERPOOL BC NSW 1871
Ethics committee country [1] 305301 0
Australia
Date submitted for ethics approval [1] 305301 0
22/11/2019
Approval date [1] 305301 0
04/02/2020
Ethics approval number [1] 305301 0
2019/ETH13683

Summary
Brief summary
The purpose of this study is to find out how effective and safe acupuncture is in treating cancer related pain.

Who is it for?
You may be eligible for this study if you are aged 18 or older, and have documented cancer related pain due to cancer of any type.

Study details
Participants in this study will be randomised by chance (like flipping a coin) into two groups. One groups will start acupuncture at enrolment. This will involve two sessions of acupuncture per week (approx. 40min per session) for 4 weeks, in addition to their prescribed pain medication. The other group will continue their prescribed medication for 4 weeks after enrolment, then receive the same acupuncture as the first group. As part of this study, all participants will complete questionnaires, have an interview.

It is hoped this research will demonstrate acupuncture can be used with western medicine to relieve the pain that cancer can cause.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99914 0
Dr Qi Zhao
Address 99914 0
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country 99914 0
Australia
Phone 99914 0
+61 0480176491
Fax 99914 0
Email 99914 0
q.zhao2@westernsydney.edu.au
Contact person for public queries
Name 99915 0
Dr Qi Zhao
Address 99915 0
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country 99915 0
Australia
Phone 99915 0
+61 0480176491
Fax 99915 0
Email 99915 0
q.zhao2@westernsydney.edu.au
Contact person for scientific queries
Name 99916 0
Dr Qi Zhao
Address 99916 0
Building 24 Level 3 Room 2, Narellan Rd & Gilchrist Dr, Western Sydney University, Campbelltown, Sydney NSW 2560
Country 99916 0
Australia
Phone 99916 0
+61 0480176491
Fax 99916 0
Email 99916 0
q.zhao2@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator using details in ANZCTR record
What supporting documents are/will be available?
No other documents available
Summary results
No Results