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Trial registered on ANZCTR


Registration number
ACTRN12616000488404
Ethics application status
Approved
Date submitted
7/04/2016
Date registered
14/04/2016
Date last updated
29/07/2021
Date data sharing statement initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding chronic pain after breast cancer surgery
Scientific title
Factors Influencing pain and recovery after breast cancer surgery
Secondary ID [1] 288943 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Post-surgical Pain 298300 0
Breast Cancer 298348 0
Condition category
Condition code
Anaesthesiology 298426 298426 0 0
Pain management
Cancer 298458 298458 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure:
Breast cancer surgery

Conditions observed:
1. Persistent pain lasting more than 6 months following breast cancer surgery.
2. The patient genotype associated with moderate to severe persistent pain following breast cancer surgery.
3. The epigenetic changes associated with these candidate genes to relate these with the development of moderate to severe persistent pain after breast cancer surgery.
4. The clinical, psychological and neurophysiological factors associated with persistent pain following breast cancer surgery.
Intervention code [1] 294417 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297913 0
Chronic pain after breast cancer surgery using the Numerical Rating Scale (NRS), Brief Pain Inventory (BPI), Short Form McGill Pain Questionnaire 2 (SF-MPQI 2), Douleur Neuropathique en 4 interview (DN4 Interview),
Timepoint [1] 297913 0
6 months after primary breast cancer surgery
Primary outcome [2] 297914 0
Candidate genes associated with moderate to severe persistent pain after breast cancer surgery. Analysing Single Nucleotide Polymorphisms (SNPs) of genes from patient DNA extracted from blood using PCR-RFLP and Sequenom MassARRAY iPlex technology.
Timepoint [2] 297914 0
6 months after primary breast cancer surgery
Primary outcome [3] 297915 0
Longitudinal epigenetic changes of the candidate genes associated with persistent pain after breast cancer surgery. Analysing longitudinal changes to mRNA by quantitative PCR of the RT–PCR cDNA product using appropriate TaqMan (Registered Trademark) Gene Expression Assay probes to assess transcriptional expression of candidate genes extracted from patient blood.
Timepoint [3] 297915 0
Immediately post op (in the post anaesthesia care unit), 24 hours, 2 weeks and 6 months after primary breast cancer surgery
Secondary outcome [1] 322604 0
Functional impairment in patients with moderate to severe persistent pain following breast cancer surgery, using disabilities of the arm, shoulder and hand questionnaire (DASH).
Timepoint [1] 322604 0
6 months after primary breast cancer surgery
Secondary outcome [2] 322740 0
Emotional distress using Depression, Anxiety and Stress Scale questionnaire (DASS21).
Timepoint [2] 322740 0
Immediately before primary breast cancer surgery (Pre-op) and 6 months after primary breast cancer surgery
Secondary outcome [3] 322741 0
Pre-existing pain experience using Numerical Rating Scale (NRS) and Brief Pain Inventory (BPI)
Timepoint [3] 322741 0
Immediately before primary breast cancer surgery (Pre-op)
Secondary outcome [4] 322742 0
Acute post operative pain using Numerical Rating Scale (NRS)
Timepoint [4] 322742 0
Immediately post op (in the post anaesthesia care unit), 24h, and 2 weeks after primary breast cancer surgery
Secondary outcome [5] 322743 0
Acute post operative pain interference using Brief Pain Inventory (BPI)
Timepoint [5] 322743 0
24 hours, and 2 weeks after primary breast cancer surgery
Secondary outcome [6] 322744 0
Nociceptive function using Quantitative Sensory Testing (QST)
Timepoint [6] 322744 0
Immediately before primary breast cancer surgery (Pre-op) and 6 months after primary breast cancer surgery
Secondary outcome [7] 322745 0
Longitudinal epigenetic changes of the candidate genes associated with persistent pain after breast cancer surgery. Analysing DNA CpG methylation to assess longitudinal expression of candidate genes extracted from patient blood using Sequenom MassARRAY.
Timepoint [7] 322745 0
Immediately post op (in the post anaesthesia care unit), 24 hours, 2 weeks and 6 months after primary breast cancer surgery
Secondary outcome [8] 322746 0
Risk factor for developing persistent pain after breast cancer surgery. Review of patient demographics, medical and surgical record.
Timepoint [8] 322746 0
6 months after primary breast cancer surgery

Eligibility
Key inclusion criteria
1. Diagnosis of breast cancer
2. Undergoing surgery for breast cancer (mastectomy, breast conserving surgery with sentinel node biopsy and / or axillary clearance)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous aesthetic surgery.
2. Patients who are unable to understand English.
3. Patients who are unable to give informed consent.
4. Patients with recurrent disease or distant metastases.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2016
Actual
7/10/2016
Date of last participant enrolment
Anticipated
3/06/2019
Actual
18/08/2020
Date of last data collection
Anticipated
Actual
3/09/2020
Sample size
Target
220
Accrual to date
Final
173
Recruitment outside Australia
Country [1] 7788 0
New Zealand
State/province [1] 7788 0
Auckland

Funding & Sponsors
Funding source category [1] 293308 0
Hospital
Name [1] 293308 0
North Shore Hospital
Country [1] 293308 0
New Zealand
Funding source category [2] 302426 0
Charities/Societies/Foundations
Name [2] 302426 0
ANZCA research foundation
Country [2] 302426 0
Australia
Primary sponsor type
Individual
Name
Dr Daniel Chiang
Address
Department of Anaesthesiology and Perioperative Medicine,
North Shore Hospital, Private Bag 93503,
Takapuna, North Shore City 0740
Country
New Zealand
Secondary sponsor category [1] 292119 0
None
Name [1] 292119 0
None
Address [1] 292119 0
none
Country [1] 292119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294782 0
Health and Disability Ethics Committee
Ethics committee address [1] 294782 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 294782 0
New Zealand
Date submitted for ethics approval [1] 294782 0
07/04/2016
Approval date [1] 294782 0
04/07/2016
Ethics approval number [1] 294782 0
16/NTA/55

Summary
Brief summary
Significance:
International studies indicate that 35%-60% of patients experience persistent pain after breast cancer surgery, impacting negatively on physical function and quality of life. There is a paucity of data from Australasia. As surgery is the major treatment modality for over 3000 new cases of breast cancer diagnosed each year in New Zealand alone, it can be postulated that persistent pain after breast cancer surgery is a large but unmeasured occult problem.
Context:
The project is a single centre study at Waitemata District Health Board, a tertiary referral centre consisting of three surgical sites, that conducts more than 400 surgeries for breast cancer annually. It will involve specialist researchers from North Shore Hospital (Pain Medicine and Anaesthesia), The University of Auckland (Pharmacogenetics and Epigenetics), AUT University (Pain Neurobiology) and The University of Adelaide (Genetics and Opioids).
Aims and Objectives:
1). To assess the relationship between patients’ genotype and the risk of developing moderate to severe persistent pain after breast cancer surgery.
2). To investigate possible epigenetic mechanisms influencing the transcription of key candidate genes to provide a possible mechanism for developing persistent pain following breast cancer surgery.
3). To assess the relationship between clinical, psychological and neurophysiological factors with persistent pain after breast cancer surgery.
Hypothesis:
1). Inherited polymorphisms in certain genes are associated with an increased risk for developing moderate to severe persistent pain after breast cancer surgery.
2). Epigenetic regulation of transcription of these genes underlies the transition to persistent pain after breast cancer surgery.
3). A combination of clinical, psychological, neurophysiological and genetic factors will be predictors of persistent pain after breast cancer surgery.
Design and Methods:
Prospective cohort study of patients undergoing breast cancer surgery. Patient review before surgery, immediately after surgery, at 24 h, 2 weeks and 6 months. Pain measurement and blood collection for candidate gene analysis and longitudinal epigenetic regulation association studies at each review. Quantitative Sensory Testing (QST) preoperatively and at 6 months.
Outcomes:
1). Incidence of persistent pain for more than 6 months after breast cancer surgery.
2). Identification of genes associated with moderate to severe persistent pain (NRS greater than 4).
3). Identification of longitudinal epigenetic regulation of genes associated with developing moderate to severe persistent pain.
4). Identification of clinical, psychological and neurophysiological factors associated with moderate to severe persistent pain.
Inclusion Criteria:
Women, 18 years and over, Undergoing breast cancer surgery (Mastectomy, Breast conserving surgery with sentinel node biopsy and/or axillary clearance)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64470 0
Dr Daniel Chiang
Address 64470 0
Department of Anaesthesiology and Perioperative Medicine,
North Shore Hospital, Private Bag 93503,
Takapuna, North Shore City 0740
Country 64470 0
New Zealand
Phone 64470 0
+64 21 027 67 220
Fax 64470 0
Email 64470 0
[email protected]
Contact person for public queries
Name 64471 0
Daniel Chiang
Address 64471 0
Department of Anaesthesiology and Perioperative Medicine,
North Shore Hospital, Private Bag 93503,
Takapuna, North Shore City 0740
Country 64471 0
New Zealand
Phone 64471 0
+64 21 027 67 220
Fax 64471 0
Email 64471 0
[email protected]
Contact person for scientific queries
Name 64472 0
Daniel Chiang
Address 64472 0
Department of Anaesthesiology and Perioperative Medicine,
North Shore Hospital, Private Bag 93503,
Takapuna, North Shore City 0740
Country 64472 0
New Zealand
Phone 64472 0
+64 21 027 67 220
Fax 64472 0
Email 64472 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
Patients are deidentified and this study does not involve an intervention.


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.