Breast CancerNCT01738048
Persistent Pain After Reconstruction Following Mastectomy
An observational study of Breast Cancer and Chronic Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Chronic Pain
- What is being tested?
- Reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 1,352 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Apr 2008
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Nationwide cross-sectional cohort
Who may be able to join
- Patients with unilateral primary breast cancer aged 18-70 years
Who cannot join
- recurrent cancer
- other malignancy
- emigration
- non-standardized treatment
Trial locations and contacts
1 site in 1 country.
About this study
A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.
Read the detailed description
The aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.
- Conditions
- Breast Cancer, Chronic Pain
- Being tested
- Reconstruction
- Keywords
- Pain, Neuropathic pain, Chronic pain
- Medical subject headings
- Breast Neoplasms, Chronic Pain, Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReconstructionProcedure or surgery
Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Mastectomy | Patients treated with mastectomy without reconstruction | |
| Reconstruction | Patients treated with mastectomy followed by reconstruction Receives: Procedure: Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of developing persistent if reconstructed
The risk of developing persistent if reconstructed compared to patients mastectomized without reconstruction expressed as an odds ratio.
Measured: Cross-sectional, 2-3 years after surgery for breast cancer
Secondary outcomes (2)
Prevalence of persistent pain after reconstruction after mastectomy
Self reported pain expressed as a percentage of the population of patients reconstructed with expander and autologous tissue. Pain intensity measured with a numerical rating scale 0-10, divided in mild (NRS 1-3), moderate (4-6) and severe pain (7-10). Patients regarded as having clinically relevant pain: NRS 4 or above, at least at a weekly basis.
Measured: Cross-sectional, 2-3 years after surgery for breast cancer
Prevalence of sensory disturbances after reconstruction after mastectomy
Measured: Cross-sectional, 2-3 years after surgery for breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Copenhagen University Hospital, RigshospitaletThe 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
- 1,352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Breast Cancer Cooperative Group
- Responsible party
- Principal investigator, Kenneth Geving Andersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kenneth G Andersen, MD, Principal investigator, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738048
- Sponsor's protocol ID
- H-D-2007-0099B
- Status last verified
- Nov 2012
- First submitted
- 22 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
PubMed 21435953
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pain After Reconstruction Following Mastectomy
- ClinicalTrials.gov ID
- NCT01738048
- Acronym / sponsor ID
- H-D-2007-0099B
- Conditions
- Breast Cancer, Chronic Pain
- Keywords
- Pain, Neuropathic pain, Chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,352 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Breast Cancer Cooperative Group
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 30 Nov 2012 (estimated)
- 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.
A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.
Detailed description
The aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mastectomy | – | –Patients treated with mastectomy without reconstruction |
| Reconstruction | – | Procedure: ReconstructionPatients treated with mastectomy followed by reconstruction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nationwide cross-sectional cohort
Key inclusion criteria (1 listed)
- Patients with unilateral primary breast cancer aged 18-70 years
Key exclusion criteria (4 listed)
- recurrent cancer
- other malignancy
- emigration
- non-standardized treatment
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 |
|---|---|---|
| ReconstructionReconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction | Procedure or surgery | Reconstruction |
Primary outcome
The risk of developing persistent if reconstructed
Time frame: Cross-sectional, 2-3 years after surgery for breast cancer
The risk of developing persistent if reconstructed compared to patients mastectomized without reconstruction expressed as an odds ratio.
2 secondary outcomes
Prevalence of persistent pain after reconstruction after mastectomy
Time frame: Cross-sectional, 2-3 years after surgery for breast cancer
Prevalence of sensory disturbances after reconstruction after mastectomy
Time frame: Cross-sectional, 2-3 years after surgery for breast cancer
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 30 Nov 2012.
- Background: PubMed 21435953Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
Related trials for Breast Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
Not yet recruitingPhase 2
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Breast Cancer, Advanced Breast Cancer
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
RecruitingPhase 2
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
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.
Kenneth G Andersen, MD principal investigator
Rigshospitalet, University of Copenhagen
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 Breast Cancer and Chronic Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 4 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 30 Nov 2012. 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 Denmark. 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?
The risk of developing persistent if reconstructed (time frame: Cross-sectional, 2-3 years after surgery for breast cancer). 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 NCT01738048, which also lists 1 linked publication.
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 30 Nov 2012.