Clinical trial · Observational
Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome
Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome - A Multi-centre Prospective Cohort Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multi-centre, prospective study aims to obtain a precise estimate of the local incidence of PMPS and identify biopsychosocial risk factors contributing to the development of PMPS. Recognition of the impact of PMPS on function and mood and quality of life in cancer survivors, and identification of risk factors would help physicians institute appropriate pre-operative counselling and preventive measures to reduce the development of PMPS. The investigators aim to follow up on the long-term multi-dimensional effects of PMPS, and continue to develop and validate a risk prediction model for patients at risk of PMPS in the next phase of the study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Post-mastectomy Pain Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Precise estimate of the local incidence and clinical/functional impact of PMPS
- timeFrame
- 4 months
- description
- Hypothesized to result from damage to major peripheral nerves during surgery. The International Association for the Study of Pain (IASP) defines PMPS as persistent pain soon after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. The primary outcome will be the local incidence of PMPS at 4 months follow-up after surgery.
Secondary outcomes (2)
- measure
- Identify risk factors of PMPS
- timeFrame
- 4 months
- description
- Describe patient, anaesthetic and surgical factors (both modifiable and unmodifiable) contributing to the development of PMPS.
- measure
- Describe factors likely to prevent or reduce the development of PMPS after breast cancer surgery
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 21-80 years old * Provided consent for the study * Types of breast surgery included: single or bilateral site mastectomies, with or without axillary clearance, wide excision with axillary clearance, radical mastectomies with or without flap surgery. Exclusion Criteria: 1. Age below 21 or above 80 years old 2. Male patients 3. Cognitive impairment/ uncommunicative patients.
References
Publications (2)
- BACKGROUNDLarsson IM, Ahm Sorensen J, Bille C. The Post-mastectomy Pain Syndrome-A Systematic Review of the Treatment Modalities. Breast J. 2017 May;23(3):338-343. doi: 10.1111/tbj.12739. Epub 2017 Jan 30. PMID 28133848
- RESULTTait RC, Zoberi K, Ferguson M, Levenhagen K, Luebbert RA, Rowland K, Salsich GB, Herndon C. Persistent Post-Mastectomy Pain: Risk Factors and Current Approaches to Treatment. J Pain. 2018 Dec;19(12):1367-1383. doi: 10.1016/j.jpain.2018.06.002. Epub 2018 Jun 30. PMID 29966772