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Pain ThresholdEarly Phase 1NCT00739544

Chronic Pain After Operation for Breast Cancer

A Early Phase 1 study testing 1 in people with Pain Threshold, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains. Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pain Threshold
What is being tested?
1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
Aug 2008to Mar 2010
Phase
Early Phase 1
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 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy women

Who cannot join

  • Pregnancy
  • Lactating

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (university of Copenhagen)

    Copenhagen, 1159

Other trials in Denmark

About this study

Official title: Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer

The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains.

Read the detailed description

Surgery for breast cancer is followed by acute undesirable sequelae (pain, nausea, vomiting, psycho-social adaptation) and late sequelae with discomfort or more severe neuropathic pain problems in the surgical area due to nerve damage or adjuvant-/radiotherapy. The late sequelae occur in 30-50% of patients but the exact mechanisms (preoperative disposing factors, intraoperative nerve damage/inflammatory response), acute postoperative pain and psychosocial factors remain to be determined in large, detailed, well-described studies, including stratification to modern breast cancer treatment (sentinel node strategy/ radiotherapy/ chemotherapy). The present study will describe in detail preoperative psychosocial/genetic pain mechanisms, intraoperative technique, multi-modal anaesthesia and opioid-reduced analgesia with a detailed, early and late postoperative follow-up with neurophysiological assessment in the surgical area and randomised studies on preventive therapy.

Conditions
Pain Threshold
Being tested
1
Keywords
Reference Values, Sensory Thresholds, Pain Threshold, Breast Neoplasms
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1Other

    Testing with thermal sensor testing device, von Frey filaments, cotton wisp, turning fork, pressure gauge device

Study groups in NCT00739544
Study groupRoleWhat they receive
1OtherQuantitative sensory testing (QST) of healthy women to create reference values for QST evaluation of women treated for breast cancer
Receives: Other: 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reference values on: Cold and cold detection threshold,Paradoxical heat sensation,Thermal sensory limen procedure,Cold and heat pain threshold,Mechanical detection and pain threshold and sensitivity,Vibration detection threshold,Pressure pain threshold

    Measured: From 08-20-2008 to 11-1-2008 test is performed two times with app one week in between

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionMar 2010 (estimated)
  4. Study completionMar 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00739544
Sponsor's protocol ID
RH2101project.1.2008
Status last verified
Aug 2008
First submitted
20 Aug 2008
Last updated
21 Aug 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 1 in people with Pain Threshold, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Aug 2008. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Reference values on: Cold and cold detection threshold,Paradoxical heat sensation,Thermal sensory limen procedure,Cold and heat pain threshold,Mechanical detection and pain threshold and sensitivity,Vibration detection threshold,Pressure pain threshold (time frame: From 08-20-2008 to 11-1-2008 test is performed two times with app one week in between). 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 NCT00739544.

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 21 Aug 2008; AzTrials last refreshed its copy on 6 Nov 2026.

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