Breast CancerNCT01523132
Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
An observational study of Breast Cancer and Persistent Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Persistent Pain, Lymphedema
- How many people
- 545 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Nov 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients treated in a university hospital
Who may be able to join
- Diagnosed with breast cancer
- 18 years or older
Who cannot join
- unable to give written consent
- unable to understand Danish
- Previous cosmetic surgery in the breast
- Previous surgery in ipsilateral breast
- Bilateral cancer
- Concomitant corrective surgery on contralateral side
Show all 10Show fewer
- Pregnant
- Other disease or injury in the nervous system
- Psychiatric disease
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Copenhagen University Hospital
Copenhagen, DK-2100
About this study
The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain.
Read the detailed description
The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.
- Conditions
- Breast Cancer, Persistent Pain, Lymphedema, Neuropathic Pain, Neuropathy
- Medical subject headings
- Breast Neoplasms, Lymphedema, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Female breast cancer patients without metastasis and locally advanced disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors predisposing for persistent pain after breast cancer treatment
Pre-, intra- and postoperative risk factors predisposing for persistent pain
Measured: 12 months postoperative
Secondary outcomes (8)
Prevalence of persistent pain after breast cancer treatment
Measured: 12 months postoperative
Prevalence of sensory disturbances after breast cancer treatment
Measured: 12 months
Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve
Measured: 12 months
Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors
Measured: 12 months
Genetic markers and the development of persistent pain after breast cancer treatment
Measured: 12 months postoperative
QST profile 1 week after surgery for breast cancer
Detailed QST profile 1 week after surgery for breast cancer. Patients will be assessed with sensory mapping, followed by assessment of mechanical and thermal thresholds.
Measured: 1 week postoperative
Acute pain after surgery for breast cancer
Prevalence of acute pain 1 week after surgery for breast cancer.
Measured: 1 week postoperative
Test-Retest of QST after breast cancer treatment
A test-retest series of a subgroup of patients assessed with QST, to evaluate methodological reliability. Patients are scheduled to 2 QST assessments with a week between.
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Breast Cancer Cooperative Group, Danish Cancer Society
- Responsible party
- Principal investigator, Kenneth Geving Andersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kenneth Geving Andersen, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletHenrik Kehlet, MD, PhD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523132
- Sponsor's protocol ID
- H-D-2007-0098
- Status last verified
- Apr 2016
- First submitted
- 27 Jan 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 21435953Andersen KG, Duriaud HM, Jensen HE, Kroman N, Kehlet H. Predictive factors for the development of persistent pain after breast cancer surgery. Pain. 2015 Dec;156(12):2413-2422. doi: 10.1097/j.pain.0000000000000298.
PubMed 26176893Andersen KG, Kehlet H, Aasvang EK. Test-retest agreement and reliability of quantitative sensory testing 1 year after breast cancer surgery. Clin J Pain. 2015 May;31(5):393-403. doi: 10.1097/AJP.0000000000000136.
PubMed 25084072Andersen KG, Duriaud HM, Aasvang EK, Kehlet H. Association between sensory dysfunction and pain 1 week after breast cancer surgery: a psychophysical study. Acta Anaesthesiol Scand. 2016 Feb;60(2):259-69. doi: 10.1111/aas.12641. Epub 2015 Oct 8.
PubMed 26446738Andersen KG, Aasvang EK, Kroman N, Kehlet H. Intercostobrachial nerve handling and pain after axillary lymph node dissection for breast cancer. Acta Anaesthesiol Scand. 2014 Nov;58(10):1240-8. doi: 10.1111/aas.12393.
PubMed 25307709
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
- ClinicalTrials.gov ID
- NCT01523132
- Acronym / sponsor ID
- H-D-2007-0098
- Conditions
- Breast Cancer, Persistent Pain, Lymphedema, Neuropathic Pain, Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Breast Cancer Cooperative Group, Danish Cancer Society
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Feb 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.
The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain.
Detailed description
The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | –Female breast cancer patients without metastasis and locally advanced disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients treated in a university hospital
Key inclusion criteria (2 listed)
- Diagnosed with breast cancer
- 18 years or older
Key exclusion criteria (10 listed)
- unable to give written consent
- unable to understand Danish
- Previous cosmetic surgery in the breast
- Previous surgery in ipsilateral breast
- Bilateral cancer
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
Risk factors predisposing for persistent pain after breast cancer treatment
Time frame: 12 months postoperative
Pre-, intra- and postoperative risk factors predisposing for persistent pain
8 secondary outcomes
Prevalence of persistent pain after breast cancer treatment
Time frame: 12 months postoperative
Prevalence of sensory disturbances after breast cancer treatment
Time frame: 12 months
Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve
Time frame: 12 months
Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors
Time frame: 12 months
Genetic markers and the development of persistent pain after breast cancer treatment
Time frame: 12 months postoperative
QST profile 1 week after surgery for breast cancer
Time frame: 1 week postoperative
Acute pain after surgery for breast cancer
Time frame: 1 week postoperative
Test-Retest of QST after breast cancer treatment
Time frame: 12 months postoperative
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 6 Apr 2016.
- 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.
- Results publication: PubMed 26176893Andersen KG, Duriaud HM, Jensen HE, Kroman N, Kehlet H. Predictive factors for the development of persistent pain after breast cancer surgery. Pain. 2015 Dec;156(12):2413-2422. doi: 10.1097/j.pain.0000000000000298.
- Results publication: PubMed 25084072Andersen KG, Kehlet H, Aasvang EK. Test-retest agreement and reliability of quantitative sensory testing 1 year after breast cancer surgery. Clin J Pain. 2015 May;31(5):393-403. doi: 10.1097/AJP.0000000000000136.
- Results publication: PubMed 26446738Andersen KG, Duriaud HM, Aasvang EK, Kehlet H. Association between sensory dysfunction and pain 1 week after breast cancer surgery: a psychophysical study. Acta Anaesthesiol Scand. 2016 Feb;60(2):259-69. doi: 10.1111/aas.12641. Epub 2015 Oct 8.
- Results publication: PubMed 25307709Andersen KG, Aasvang EK, Kroman N, Kehlet H. Intercostobrachial nerve handling and pain after axillary lymph node dissection for breast cancer. Acta Anaesthesiol Scand. 2014 Nov;58(10):1240-8. doi: 10.1111/aas.12393.
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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.
Kenneth Geving Andersen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Henrik Kehlet, MD, PhD study chair
Copenhagen University Hospital, Rigshospitalet
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 Persistent 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 2 inclusion and 10 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 6 Apr 2016. 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?
Risk factors predisposing for persistent pain after breast cancer treatment (time frame: 12 months postoperative). 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 NCT01523132, which also lists 5 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 6 Apr 2016.