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Sponsors and Collaborators: |
Rigshospitalet, Denmark Danish Breast Cancer Cooperative Group Danish Cancer Society |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00739544 |
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 |
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 |
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
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (university of Copenhagen) | |
Copenhagen, Denmark, 1159 |
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: | Department of Breast Cancer Surgery, RH, Copenhagen University, Denmark ( Rune Gärtner MD ) |
Study ID Numbers: | RH2101project.1.2008 |
Study First Received: | August 20, 2008 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00739544 History of Changes |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
Reference Values Sensory Thresholds Pain Threshold Breast Neoplasms |
Skin Diseases Breast Neoplasms Pain Healthy Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |