Breast CancerPMPSNCT04989179
Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome
An observational study of Breast Cancer and Post-mastectomy Pain Syndrome, run by Singapore General Hospital at 3 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Post-mastectomy Pain Syndrome
- How many people
- 220 participants
- Where
- 3 sitesSingapore
- Study dates
- 28 Oct 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age below 21 or above 80 years old
- Male patients
- Cognitive impairment/ uncommunicative patients.
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
Singapore General hospital
Singapore, Singapore, 169608
Changi General Hospital
Singapore
KK Women's and Children's Hospital
Singapore
About this study
Official title: Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome - A Multi-centre Prospective Cohort Study.
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.
Read the 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 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.
- Conditions
- Breast Cancer, Post-mastectomy Pain Syndrome
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
Identify risk factors of PMPS
Describe patient, anaesthetic and surgical factors (both modifiable and unmodifiable) contributing to the development of PMPS.
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start28 Oct 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Chan, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989179
- Sponsor's protocol ID
- PMPS 1
- Acronym
- PMPS
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2021
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28133848Tait 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.
PubMed 29966772
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome - A Multi-centre Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04989179
- Acronym / sponsor ID
- PMPS / PMPS 1
- Conditions
- Breast Cancer, Post-mastectomy Pain Syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Age below 21 or above 80 years old
- Male patients
- Cognitive impairment/ uncommunicative patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Precise estimate of the local incidence and clinical/functional impact of PMPS
Time frame: 4 months
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.
2 secondary outcomes
Identify risk factors of PMPS
Time frame: 4 months
Describe factors likely to prevent or reduce the development of PMPS after breast cancer surgery
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 28133848Larsson 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.
- Results publication: PubMed 29966772Tait 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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Chan principal investigator
Singapore General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Post-mastectomy Pain Syndrome, run by Singapore General Hospital at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precise estimate of the local incidence and clinical/functional impact of PMPS (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04989179, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.