ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Pain After Operation for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00739544
Recruitment Status : Unknown
Verified August 2008 by Rigshospitalet, Denmark.
Recruitment status was:  Enrolling by invitation
First Posted : August 21, 2008
Last Update Posted : August 21, 2008
Sponsor:
Collaborators:
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Information provided by:
Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Pain Threshold Other: 1 Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer
Study Start Date : August 2008
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 [ Time Frame: From 08-20-2008 to 11-1-2008 test is performed two times with app one week in between ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women

Exclusion Criteria:

  • Pregnancy
  • Lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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

Responsible Party: Rune Gärtner MD, Department of Breast Cancer Surgery, RH, Copenhagen University, Denmark
ClinicalTrials.gov Identifier: NCT00739544     History of Changes
Other Study ID Numbers: RH2101project.1.2008
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008

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

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms