Lung CancerNCT01300702
Neuropathic in the Acute Post Operative Phase
An observational study of Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Investigation of thermal thresholds and sensory mapping to thermal stimuli Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 0 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2011to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients undergoing thoracotomy
Who may be able to join
- age > 18 years old
Who cannot join
- do not under stand Danish
- cognitive reduction
- previous thoracic surgery
- Pregnant or nursing
- inability to cooperate to pain scoring
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Section for Surgical Pathophysiology 4074
Copenhagen, 2100
About this study
Official title: Identification of Neuropathic Pain in the Acute Post Operative Phase Following Thoracotomy
Investigation of thermal thresholds and sensory mapping to thermal stimuli
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
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 |
|---|---|---|
| lung cancer surgery | Patients undergoing thoracotomy for lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
pain intensity
Measured: 14 days
quantitative sensory testing (QST)
thermal thresholds assesses via QST
Measured: 14 days
Neuropathic pain
is the pain considered neuropathic
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Section for Surgical Pathophysiology, Section of Acute Pain Management and Palliative Medicine, Multidisciplinary Pain Centre, Innovative Medicines Initiative
- Investigators
- Henrik Kehlet, MD, Study chair, Section for Surgical PathophysiologyKim Wildgaard, MD, Principal investigator, Section for Surgical Pathophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300702
- Sponsor's protocol ID
- H4-2010-118#1
- Status last verified
- Sep 2011
- First submitted
- 22 Feb 2011
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Neuropathic Pain in the Acute Post Operative Phase Following Thoracotomy
- ClinicalTrials.gov ID
- NCT01300702
- Acronym / sponsor ID
- H4-2010-118#1
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Section for Surgical Pathophysiology, Section of Acute Pain Management and Palliative Medicine, Multidisciplinary Pain Centre, Innovative Medicines Initiative
- Study start
- Feb 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Feb 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.
Investigation of thermal thresholds and sensory mapping to thermal stimuli
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer surgery | – | –Patients undergoing thoracotomy for lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients undergoing thoracotomy
Key inclusion criteria (1 listed)
- age > 18 years old
Key exclusion criteria (5 listed)
- do not under stand Danish
- cognitive reduction
- previous thoracic surgery
- Pregnant or nursing
- inability to cooperate to pain scoring
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
Pain
Time frame: 14 days
pain intensity
quantitative sensory testing (QST)
Time frame: 14 days
thermal thresholds assesses via QST
Neuropathic pain
Time frame: 14 days
is the pain considered neuropathic
Results and safety
The study was stopped early (reason given: recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
Henrik Kehlet, MD study chair
Section for Surgical Pathophysiology
Kim Wildgaard, MD principal investigator
Section for Surgical Pathophysiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 5 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 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: recruitment 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?
Pain (time frame: 14 days). The study lists 3 primary outcomes in all. 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 29 Sep 2011.