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Chronic Pain After Operation for Breast Cancer

This study is enrolling participants by invitation only.

Sponsors and Collaborators: Rigshospitalet, Denmark
Danish Breast Cancer Cooperative Group
The Danish Cancer Society
Information provided by: Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00739544
  Purpose

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.


Condition Intervention Phase
Pain Threshold
Other: 1
Phase 0

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Single Blind (Subject), Single Group Assignment
Official Title:   Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:   20
Study Start Date:   August 2008
Estimated Study Completion Date:   March 2010
Estimated Primary Completion Date:   March 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1
Quantitative sensory testing (QST) of healthy women to create reference values for QST evaluation of women treated for breast cancer
Other: 1
Testing with thermal sensor testing device, von Frey filaments, cotton wisp, turning fork, pressure gauge device

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.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Healthy women

Exclusion Criteria:

  • Pregnancy
  • Lactating
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739544

Locations
Denmark
Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (university of Copenhagen)    
      Copenhagen, Denmark, 1159

Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Breast Cancer Cooperative Group
The Danish Cancer Society

Investigators
Study Director:     Niels Kroman, MD, DMSc     Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (University of Copenhagen), Denmark    
Study Chair:     Henrik Kehlet, MD Ph.D DMSc     Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet (University of Copenhagen), Denmark    
  More Information


Responsible Party:   Department of Breast Cancer Surgery, RH, Copenhagen University, Denmark ( Rune Gärtner MD )
Study ID Numbers:   RH2101project.1.2008
First Received:   August 20, 2008
Last Updated:   August 20, 2008
ClinicalTrials.gov Identifier:   NCT00739544
Health Authority:   Denmark: The Regional Committee on Biomedical Research Ethics;   Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Reference Values  
Sensory Thresholds  
Pain Threshold  
Breast Neoplasms  

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Pain
Healthy
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 15, 2008




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