Breast NeoplasmsNCT01279018
Persistent Pain After Breast Cancer Treatment With Docetaxel
An observational study of Breast Neoplasms and Pain, Postoperative, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86%… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms, Pain, Postoperative, Neuralgia
- How many people
- 2,490 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jan 2011
- 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
- Adult, Older adult
Study population: Patients treated for breast cancer in Denmark 2007 and 2008
Who may be able to join
- Treated for primary breast cancer in Denmark 2007-2008
- Age between 18-80 years
- No recurrent cancer
- Female
Who cannot join
- Previous breast surgery same side (including plastic and reconstructive surgery)
- Bilateral breast surgery
- Recurrent cancer or metastatic cancer
About this study
Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.
- Conditions
- Breast Neoplasms, Pain, Postoperative, Neuralgia, Lymphedema
- Keywords
- Persistent postsurgical pain, breast cancer, postmastectomy pain syndrome, neuropathic pain
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Neuralgia, Lymphedema
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 |
|---|---|---|
| Patients treated with docetaxel | Patients treated according to the DBCG 07 protocol, that have received docetaxel as part of the adjuvant treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Docetaxel as a risk factor for development of persistent pain
Measured: Between 2-3 years post surgery
Secondary outcomes (1)
Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations
Measured: Between 2-3 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- 2,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279018
- Sponsor's protocol ID
- H-1-2010-028
- Status last verified
- Jun 2010
- First submitted
- 14 Jan 2011
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pain After Breast Cancer Treatment With Docetaxel
- ClinicalTrials.gov ID
- NCT01279018
- Acronym / sponsor ID
- H-1-2010-028
- Conditions
- Breast Neoplasms, Pain, Postoperative, Neuralgia, Lymphedema
- Keywords
- Persistent postsurgical pain, breast cancer, postmastectomy pain syndrome, neuropathic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,490 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Jan 2011 (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.
Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with docetaxel | – | –Patients treated according to the DBCG 07 protocol, that have received docetaxel as part of the adjuvant treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients treated for breast cancer in Denmark 2007 and 2008
Key inclusion criteria (4 listed)
- Treated for primary breast cancer in Denmark 2007-2008
- Age between 18-80 years
- No recurrent cancer
- Female
Key exclusion criteria (3 listed)
- Previous breast surgery same side (including plastic and reconstructive surgery)
- Bilateral breast surgery
- Recurrent cancer or metastatic 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
Docetaxel as a risk factor for development of persistent pain
Time frame: Between 2-3 years post surgery
1 secondary outcome
Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations
Time frame: Between 2-3 years post surgery
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 19 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Pain, Postoperative, run by Copenhagen University Hospital, Rigshospitalet.
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 4 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 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Docetaxel as a risk factor for development of persistent pain (time frame: Between 2-3 years post surgery). 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 19 Jan 2011.