Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome

NCT04989179 | Active Not Recruiting DMC

• 1 other identifier: PMPS 1
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 3

Brief Summary

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

Breast Cancer; Post-mastectomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Precise estimate of the local incidence and clinical/functional impact of PMPS

  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.

  4 months

Secondary Outcomes (2)

• Identify risk factors of PMPS

  4 months

• Describe factors likely to prevent or reduce the development of PMPS after breast cancer surgery

  4 months

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: Only female patients will be recruited as breast cancer in male is very rare.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surgeons at the breast clinic listing patients for surgery will inform patients of the study. The clinical research coordinators will approach the potential study participants referred by the study team members and other attending pain clinicians.

You may qualify if:

• 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.

You may not qualify if:

• Age below 21 or above 80 years old
• Male patients
• Cognitive impairment/ uncommunicative patients.

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (3)

Singapore General hospital

Singapore, Singapore, 169608, Singapore

Location

Changi General Hospital

Singapore, Singapore

Location

KK Women's and Children's Hospital

Singapore, Singapore

Location

Related Publications (2)

• Larsson 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 BACKGROUND

• Tait 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 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Diana Chan

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: August 4, 2021
• Study Start: October 28, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)