Breast CancerNCT01543711
Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment
An observational study of Breast Cancer and Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. The investigators have previously published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Pain, Post Operative Pain
- How many people
- 2,411 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Apr 2012
- 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: Woman treated for breast cancer in Denmark 2005-2006, and participated in the study in 2008
Who may be able to join
- Diagnosed with primary breast cancer between 2005-2006
- Participated in a study in 2008
Who cannot join
- Recurrent or new primary cancer
- Metastatic cancer
- Reconstructive surgery
Trial locations and contacts
1 site in 1 country.
About this study
Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. The investigators have previously published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006. Very few studies have examined how these late effects change in time. The aim of this study is to examine in a well defined patient population any change in the prevalence of persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor profile.
- Conditions
- Breast Cancer, Pain, Post Operative Pain, Lymphedema, Neuropathy
- Keywords
- Breast cancer, persistent pain, neuropathic pain, lymphedema
- Medical subject headings
- Breast Neoplasms, Pain, Pain, Postoperative, 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 survivors | Women treated for breast cancer, without signs of recurrence or metastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of persistent pain
Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable
Measured: 6-7 years post operative
Prevalence of patients changing pain status from the 2008 survey
Measured: 6-7 years
Secondary outcomes (6)
Prevalence of sensory disturbance
Measured: 6-7 years
Prevalence of self reported lymphedma
Measured: 6-7 years
Prevalence of functional impairment
Measured: 6-7 years
Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment
Measured: 6-7 years
Prevalence of patients changing status of sensory disturbances and self reported lymphedma
Measured: 6-7 years
Risk factors associated to changing status of sensory disturbances and lymphedema
Measured: 6-7 years post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Cross-sectional
- Enrolment
- 2,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Kenneth Geving Andersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kenneth Geving Andersen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543711
- Sponsor's protocol ID
- 2007-41-1530
- Status last verified
- Jun 2013
- First submitted
- 28 Feb 2012
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
PubMed 19903919Andersen 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 21435953Mejdahl MK, Andersen KG, Gartner R, Kroman N, Kehlet H. Persistent pain and sensory disturbances after treatment for breast cancer: six year nationwide follow-up study. BMJ. 2013 Apr 11;346:f1865. doi: 10.1136/bmj.f1865.
PubMed 23580693
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT01543711
- Acronym / sponsor ID
- 2007-41-1530
- Conditions
- Breast Cancer, Pain, Post Operative Pain, Lymphedema, Neuropathy
- Keywords
- Breast cancer, persistent pain, neuropathic pain, lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,411 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Mar 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.
Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. The investigators have previously published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006. Very few studies have examined how these late effects change in time. The aim of this study is to examine in a well defined patient population any change in the prevalence of persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor profile.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | – | –Women treated for breast cancer, without signs of recurrence or metastasis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Woman treated for breast cancer in Denmark 2005-2006, and participated in the study in 2008
Key inclusion criteria (2 listed)
- Diagnosed with primary breast cancer between 2005-2006
- Participated in a study in 2008
Key exclusion criteria (3 listed)
- Recurrent or new primary cancer
- Metastatic cancer
- Reconstructive surgery
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
Prevalence of persistent pain
Time frame: 6-7 years post operative
Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable
Prevalence of patients changing pain status from the 2008 survey
Time frame: 6-7 years
6 secondary outcomes
Prevalence of sensory disturbance
Time frame: 6-7 years
Prevalence of self reported lymphedma
Time frame: 6-7 years
Prevalence of functional impairment
Time frame: 6-7 years
Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment
Time frame: 6-7 years
Prevalence of patients changing status of sensory disturbances and self reported lymphedma
Time frame: 6-7 years
Risk factors associated to changing status of sensory disturbances and lymphedema
Time frame: 6-7 years post operative
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 Jun 2013.
- Background: PubMed 19903919Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
- 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.
- Derived from this study: PubMed 23580693Mejdahl MK, Andersen KG, Gartner R, Kroman N, Kehlet H. Persistent pain and sensory disturbances after treatment for breast cancer: six year nationwide follow-up study. BMJ. 2013 Apr 11;346:f1865. doi: 10.1136/bmj.f1865.
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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
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 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 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: finished, as of the sponsor's last update on 6 Jun 2013. 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?
Prevalence of persistent pain (time frame: 6-7 years post operative). The study lists 2 primary outcomes in all. 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 NCT01543711, which also lists 3 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 Jun 2013.