Breast CancerNCT01392248
Prediction of Pain After Breast Cancer Surgery With EEG
An observational study of Breast Cancer and Postoperative Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
1. Rationale The inter-individual pain experience immediately after surgery is considerable. In addition, a number of patients develop chronic post surgery pain (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both acute post surgical pain as well as CPSP. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Postoperative Pain, Chronic Pain
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Feb 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: One hundred and fifty female patients undergoing elective breast cancer surgery in day-case surgery.
Who may be able to join
- Age 18 - 65 years.
- ASA 1-2.
- Sufficient comprehension of the Dutch spoken and written language.
- Elective curative breast cancer surgery, both mastectomy and breast- conserving therapy
- Stage I and II breast cancer.
- Written informed consent is obtained
Who cannot join
- Previous breast surgery, both ipsilateral and contralateral.
- Stage III-IV breast cancer.
- Chronic pain (>3months) with an average severity of at least a VAS score 4 during the last two weeks.
- Chronic pain for which invasive treatment is needed.
- Use of (weak / strong) opioids in the last week.
- A history of opioid addiction.
Show all 15Show fewer
- Regular use of the following medications in the last year:
- antiepileptics,antipsychotics and anxiolytics.
- ASA 3 or higher.
- Consumption of alcohol (>4 units) and / or drugs the evening before.
- Alcohol consumption (>= 5 units/day).
- Illiteracy, problems with self expression, language barrier.
- Serious vision and / or hearing problems, interfering the performance of the experimental tasks.
- A history of psychiatric complaints and/or epilepsy .
- A medical history of CVA or TIA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EEG as a Predictor for Postoperative Pain and the Development of Chronic Postsurgical Pain After Breast Cancer Surgery
- Rationale The inter-individual pain experience immediately after surgery is considerable. In addition, a number of patients develop chronic post surgery pain (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both acute post surgical pain as well as CPSP. Recently, in a group of patients with chronic back pain, it was demonstrated how subjectively reported pain is associated with specific electroencephalography (EEG) parameters, namely the N2 and P3 components of the pain event-related potential (ERP). It was concluded that ERP was associated with self-reported pain in daily life up to two weeks after the measurement. This resulted in the current hypothesis that EEG may be a predictor for postoperative pain.
- Study design Prospective cohort study. Within 2 weeks before surgery, 150 patients will undergo an EEG measurement with five 'vulnerability' tasks. The experiment will be repeated 6 months postoperatively. Study population: Female patients with breast cancer who will undergo breast surgery, between the ages of 18 to 65 years.
- Main study parameters/endpoints Primary outcome is postoperative pain, measured in a pain diary 4 days postoperatively. Secondary outcomes are development of chronic post surgery pain and quality of life. The main goal is to develop a comprehensive prediction model for acute and chronic postoperative pain after breast cancer surgery, based on the EEG results of the five vulnerability experiments.
- Conditions
- Breast Cancer, Postoperative Pain, Chronic Pain
- Keywords
- EEG, breast cancer surgery, prediction, acute postoperative pain, chronic pain
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperative pain
VAS measured in a daily pain diary
Measured: during 4 days after surgery
Secondary outcomes (2)
Quality of Life
Quality of Life measured with SF-36
Measured: within 2 weeks before surgery and at 3,6 and 12 months postoperatively
Development of chronic pain
Brief Pain Inventory
Measured: at 3,6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: funding and recruiting problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carine Vossen, Maastricht University Medical Center
- Investigators
- M. A Marcus, Prof. Dr., Principal investigator, Maastricht University Medical CenterJ. van Os, Prof. Dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392248
- Sponsor's protocol ID
- NL34275.068.11 / MEC 11-2-006
- Status last verified
- Nov 2013
- First submitted
- 1 Jun 2011
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG as a Predictor for Postoperative Pain and the Development of Chronic Postsurgical Pain After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT01392248
- Acronym / sponsor ID
- NL34275.068.11 / MEC 11-2-006
- Conditions
- Breast Cancer, Postoperative Pain, Chronic Pain
- Keywords
- EEG, breast cancer surgery, prediction, acute postoperative pain, chronic pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: funding and recruiting problems
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 Jul 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.
- Rationale The inter-individual pain experience immediately after surgery is considerable. In addition, a number of patients develop chronic post surgery pain (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both acute post surgical pain as well as CPSP. Recently, in a group of patients with chronic back pain, it was demonstrated how subjectively reported pain is associated with specific electroencephalography (EEG) parameters, namely the N2 and P3 components of the pain event-related potential (ERP). It was concluded that ERP was associated with self-reported pain in daily life up to two weeks after the measurement. This resulted in the current hypothesis that EEG may be a predictor for postoperative pain.
- Study design Prospective cohort study. Within 2 weeks before surgery, 150 patients will undergo an EEG measurement with five 'vulnerability' tasks. The experiment will be repeated 6 months postoperatively. Study population: Female patients with breast cancer who will undergo breast surgery, between the ages of 18 to 65 years.
- Main study parameters/endpoints Primary outcome is postoperative pain, measured in a pain diary 4 days postoperatively. Secondary outcomes are development of chronic post surgery pain and quality of life. The main goal is to develop a comprehensive prediction model for acute and chronic postoperative pain after breast cancer surgery, based on the EEG results of the five vulnerability experiments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and fifty female patients undergoing elective breast cancer surgery in day-case surgery.
Key inclusion criteria (6 listed)
- Age 18 - 65 years.
- ASA 1-2.
- Sufficient comprehension of the Dutch spoken and written language.
- Elective curative breast cancer surgery, both mastectomy and breast- conserving therapy
- Stage I and II breast cancer.
Key exclusion criteria (15 listed)
- Previous breast surgery, both ipsilateral and contralateral.
- Stage III-IV breast cancer.
- Chronic pain (>3months) with an average severity of at least a VAS score 4 during the last two weeks.
- Chronic pain for which invasive treatment is needed.
- Use of (weak / strong) opioids in the last week.
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
Acute postoperative pain
Time frame: during 4 days after surgery
VAS measured in a daily pain diary
2 secondary outcomes
Quality of Life
Time frame: within 2 weeks before surgery and at 3,6 and 12 months postoperatively
Development of chronic pain
Time frame: at 3,6 and 12 months postoperatively
Results and safety
The study was stopped early (reason given: funding and recruiting problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
M. A Marcus, Prof. Dr. principal investigator
Maastricht University Medical Center
J. van Os, Prof. Dr. principal investigator
Maastricht University Medical Center
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 Postoperative Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 28 Nov 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 Netherlands. 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 was stopped early (reason given: funding and recruiting problems). Results are not available in the source record.
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?
Acute postoperative pain (time frame: during 4 days after 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 28 Nov 2013.