MastectomyCPMPNCT06592053
Affecting Factors for Chronic Pain After Mastectomy
An observational study of Mastectomy and Pain, Chronic, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic post-mastectomy pain (CPMP) is a significant issue affecting many women after mastectomy. Factors like age, treatment type, and pre-surgery pain can increase the risk of developing this condition. By evaluating these factors, CPMP can be prevented more successfully and treatment strategies can be developed. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Mastectomy, Pain, Chronic, Pain, Acute
- What is being tested?
- Breast Cancer Surgery Pain
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2024to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-80 years, with an ASA classification of I-II-III and a body mass index (BMI) between 18-35 kg/m², who will undergo mastectomy surgery or mastectomy with axillary dissection, will be included in our study.
Who may be able to join
- Between the ages of 18-80
- BMI 18-35 kg/m2
- ASA (American Society of Anesthesiologists) Scoring I-II-III
- Elective mastectomy surgery
- Elective mastectomy and axillary dissection surgery
- Patients who will undergo general anesthesia
- Patients who agree to participate in the study and sign a form
Who cannot join
- Patients under 18 and over 80 years of age
- Patients who do not want to participate in the study
- Patients with chronic pain or chronic opioid use
- Patients with alcohol, substance or drug addiction
- Patients with a history of previous mastectomy
- Patients with limited cooperation such as dementia, psychiatric disorders
- Pregnant and breastfeeding patients will be excluded from the study
- Patients who cannot communicate in their native language will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affecting Factors for the Incidence of Chronic Pain After Mastectomy
Chronic post-mastectomy pain (CPMP) is a significant issue affecting many women after mastectomy. Factors like age, treatment type, and pre-surgery pain can increase the risk of developing this condition. By evaluating these factors, CPMP can be prevented more successfully and treatment strategies can be developed. This study aims to investigate the factors contributing to CPMP and contribute to the existing literature on this important topic.
Read the detailed description
Chronic post-mastectomy pain (CPMP) is a common condition and is a significant clinical problem with a prevalence reported in the literature of up to 50%. Approximately 10% of patients experience severe pain, which has a significant impact on their quality of life. Since mastectomy is a frequently performed procedure, this syndrome affects a large number of women. Therefore, it is important to better understand the factors associated with the development of persistent pain.
Several theories have been proposed regarding the development of CPMP, including increased peripheral nociceptor sensitivity (primary hyperalgesia) at the site of injury, central neuronal sensitivity (central hyperalgesia) in spinal and supraspinal regions innervating the injured area, and inflammatory changes triggered by the central nervous system. Recommended methods to prevent CPMP include careful dissection, reduction of inflammatory responses, and the use of minimally invasive surgical techniques to prevent peripheral and central neuronal sensitization.
Epidemiological studies-both retrospective and prospective-have identified some of these risk factors, such as younger age, chemotherapy, radiotherapy, and the presence of preoperative pain or severe acute postoperative pain. Unfortunately, there are few studies on this topic, and the literature needs further support.
The hypothesis in this study is that if investigator can identify the factors that increase chronic pain after mastectomy, investigator can take measures against these factors and reduce the development of chronic pain. Therefore, this study aims to identify the factors contributing to chronic pain after mastectomy.
- Conditions
- Mastectomy, Pain, Chronic, Pain, Acute, Breast Surgery, Breast Cancer Surgery
- Being tested
- Breast Cancer Surgery Pain
- Medical subject headings
- Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Surgery PainProcedure or surgery
Also called Breast Cancer Surgery Chronic Pain
Factors affecting the occurrence of chronic pain in patients undergoing elective mastectomy surgery will be investigated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
Patients; self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain. In this scoring, the patient can get at least 0 points. He can get a maximum of 24 points. If the patient's score is 12 or above, the possibility of neuropathic pain is considered high.
Measured: Postoperative 3rd month
Secondary outcomes (4)
Short Form 12 questionnaire in the 3rd month
Short Form 12 questionnaire will be evaluated in the 3rd month to evaluate the quality of life of the patients.
Measured: Postoperative 3rd month
Short Form 12 questionnaire in the 6th month
Short Form 12 questionnaire will be evaluated in the 6th month to evaluate the quality of life of the patients
Measured: Postoperative 6th month
Self-leeds assessment of neuropathic symptoms and sign findings at 6th months
Patients; self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain. In this scoring, the patient can get at least 0 points. He can get a maximum of 24 points. If the patient's score is 12 or above, the possibility of neuropathic pain is considered high.
Measured: Postoperative 6th month
Acute pain score
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be made at 0, 1, 24th hours in the postoperative period.
Measured: Up to 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Sep 2024
- Primary completion1 Oct 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berkant Demiray, Ankara Etlik City Hospital
- Investigators
- Musa ZENGİN, Associate Professor, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592053
- Sponsor's protocol ID
- AEŞH-BADEK-2024-414
- Acronym
- CPMP
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affecting Factors for the Incidence of Chronic Pain After Mastectomy
- ClinicalTrials.gov ID
- NCT06592053
- Acronym / sponsor ID
- CPMP / AEŞH-BADEK-2024-414
- Conditions
- Mastectomy, Pain, Chronic, Pain, Acute, Breast Surgery, Breast Cancer Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 19 Sep 2024 (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.
Chronic post-mastectomy pain (CPMP) is a significant issue affecting many women after mastectomy. Factors like age, treatment type, and pre-surgery pain can increase the risk of developing this condition. By evaluating these factors, CPMP can be prevented more successfully and treatment strategies can be developed. This study aims to investigate the factors contributing to CPMP and contribute to the existing literature on this important topic.
Detailed description
Chronic post-mastectomy pain (CPMP) is a common condition and is a significant clinical problem with a prevalence reported in the literature of up to 50%. Approximately 10% of patients experience severe pain, which has a significant impact on their quality of life. Since mastectomy is a frequently performed procedure, this syndrome affects a large number of women. Therefore, it is important to better understand the factors associated with the development of persistent pain.
Several theories have been proposed regarding the development of CPMP, including increased peripheral nociceptor sensitivity (primary hyperalgesia) at the site of injury, central neuronal sensitivity (central hyperalgesia) in spinal and supraspinal regions innervating the injured area, and inflammatory changes triggered by the central nervous system. Recommended methods to prevent CPMP include careful dissection, reduction of inflammatory responses, and the use of minimally invasive surgical techniques to prevent peripheral and central neuronal sensitization.
Epidemiological studies-both retrospective and prospective-have identified some of these risk factors, such as younger age, chemotherapy, radiotherapy, and the presence of preoperative pain or severe acute postoperative pain. Unfortunately, there are few studies on this topic, and the literature needs further support.
The hypothesis in this study is that if investigator can identify the factors that increase chronic pain after mastectomy, investigator can take measures against these factors and reduce the development of chronic pain. Therefore, this study aims to identify the factors contributing to chronic pain after mastectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-80 years, with an ASA classification of I-II-III and a body mass index (BMI) between 18-35 kg/m², who will undergo mastectomy surgery or mastectomy with axillary dissection, will be included in our study.
Key inclusion criteria (7 listed)
- Between the ages of 18-80
- BMI 18-35 kg/m2
- ASA (American Society of Anesthesiologists) Scoring I-II-III
- Elective mastectomy surgery
- Elective mastectomy and axillary dissection surgery
Key exclusion criteria (8 listed)
- Patients under 18 and over 80 years of age
- Patients who do not want to participate in the study
- Patients with chronic pain or chronic opioid use
- Patients with alcohol, substance or drug addiction
- Patients with a history of previous mastectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Cancer Surgery PainAlso: Breast Cancer Surgery Chronic PainFactors affecting the occurrence of chronic pain in patients undergoing elective mastectomy surgery will be investigated. | Procedure or surgery | – |
Primary outcome
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
Time frame: Postoperative 3rd month
Patients; self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain. In this scoring, the patient can get at least 0 points. He can get a maximum of 24 points. If the patient's score is 12 or above, the possibility of neuropathic pain is considered high.
4 secondary outcomes
Short Form 12 questionnaire in the 3rd month
Time frame: Postoperative 3rd month
Short Form 12 questionnaire in the 6th month
Time frame: Postoperative 6th month
Self-leeds assessment of neuropathic symptoms and sign findings at 6th months
Time frame: Postoperative 6th month
Acute pain score
Time frame: Up to 24 hours after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Musa ZENGİN, Associate Professor study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastectomy and Pain, Chronic, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months. (time frame: Postoperative 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.