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

Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome - A Multi-centre Prospective Cohort Study.

Phase 1 of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Post-mastectomy Pain Syndrome

Detailed Description

Post-mastectomy pain syndrome (PMPS) has been reported to occur in 25-60% of patients following surgeries for breast cancer, the highest occurring cancer in women worldwide. There is a lack of an accepted standard definition of PMPS which has resulted in the wide range of estimates of its occurrence. While there has been much research interest in this condition, there is still a paucity of standardized and effective treatment at this point, and our understanding of this condition, its exact incidence and risk factors, is still incomplete.

The local incidence of PMPS after breast cancer surgery is presently unknown and often under-reported, although breast cancer surgery is common and is carried out in almost all Singhealth institutions. Risk factors for PMPS in the local context may differ from that postulated in the West due to cultural, racial and societal differences. Breast cancer has a high survival rate, with data from the CONCORD-2 study showing a 5-year survival rate of ≥85%in developed countries. Despite high survival rates in cancer survivors, PMPS has been shown to have a negative impact on the quality of recovery(QoR), patient satisfaction, and can be severe enough causing the diminished quality of life (QoL) including poor sleep, long-term disability, mood disorders and interference with activities of daily living (ADL).

Despite widespread recognition of PMPS, it is often untreated or undertreated. Some possible reasons suggested for inadequate management of PMPS are the lack of quality information about optimal treatment, and incomplete understanding of the mechanisms and risk factors for chronic pain development and prognosis. There is therefore a knowledge gap in the understanding of risk factors leading to PMPS, the lack of a validated risk prediction model for development of PMPS, and hence limiting the institution of preventive analgesia in high risk patients. It is therefore timely to conduct a local multi-centre, prospective study to look at the local incidence of PMPS after breast surgery, the multi-dimensional effects of PMPS on the patient as well as to identify modifiable biopsychosocial risk factors leading to PMPS.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Diana Chan, MBBS/MMED (Anaesthesia), MCI; Phone Number: +6594372568; Email: dianacxh84@gmail.com

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
    • Contact: Diana Chan Xin Hui; Phone Number: 94372568; Email: diana.chan.x.h@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify risk factors of PMPS	Describe patient, anaesthetic and surgical factors (both modifiable and unmodifiable) contributing to the development of PMPS.	4 months
Describe factors likely to prevent or reduce the development of PMPS after breast cancer surgery	Identified risk factors can help to identify patients at risk of developing PMPS which then allows clinicians to institute prevention measures such as pre-operative counselling and preventive analgesics for high-risk patients with multiple risk factors	4months

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Post-mastectomy pain syndrome: A timely review of its predisposing factors and current approaches to treatment

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 25, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Syndrome; Somatoform Disorders
• Other Study ID Numbers: PMPS 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No