NCT00739544

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

1.6 years

First QC Date

August 20, 2008

Last Update Submit

August 20, 2008

Conditions

Pain Threshold

Keywords

Reference ValuesSensory ThresholdsPain ThresholdBreast Neoplasms

Outcome Measures

Primary Outcomes (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

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

Study Arms (1)

1

OTHER

Quantitative sensory testing (QST) of healthy women to create reference values for QST evaluation of women treated for breast cancer

Other: 1

Interventions

1OTHER

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

1

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy women

You may not qualify if:

  • Pregnancy
  • Lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 1159, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Niels Kroman, MD, DMSc

    Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (University of Copenhagen), Denmark

    STUDY DIRECTOR

  • Henrik Kehlet, MD Ph.D DMSc

    Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet (University of Copenhagen), Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 21, 2008

Record last verified: 2008-08

Locations

DK(1)