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Understanding chronic pain after breast cancer surgery

Factors Influencing pain and recovery after breast cancer surgery

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000488404
Enrollment
173
Registered
2016-04-14
Start date
2016-10-07
Completion date
2020-08-18
Last updated
2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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)

Interventions

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

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.

Sponsors

Dr Daniel Chiang
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026