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Chronic Pain After Operation for Breast Cancer

Primary Purpose

Pain Threshold

Status
Unknown status
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
1
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain Threshold focused on measuring Reference Values, Sensory Thresholds, Pain Threshold, Breast Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy women

Exclusion Criteria:

  • Pregnancy
  • Lactating

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 20, 2008
Last Updated
August 20, 2008
Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Breast Cancer Cooperative Group, Danish Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT00739544
Brief Title
Chronic Pain After Operation for Breast Cancer
Official Title
Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Breast Cancer Cooperative Group, Danish Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Threshold
Keywords
Reference Values, Sensory Thresholds, Pain Threshold, Breast Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Quantitative sensory testing (QST) of healthy women to create reference values for QST evaluation of women treated for breast cancer
Intervention Type
Other
Intervention Name(s)
1
Intervention Description
Testing with thermal sensor testing device, von Frey filaments, cotton wisp, turning fork, pressure gauge device
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy women Exclusion Criteria: Pregnancy Lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Kroman, MD, DMSc
Organizational Affiliation
Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (University of Copenhagen), Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Henrik Kehlet, MD Ph.D DMSc
Organizational Affiliation
Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet (University of Copenhagen), Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (university of Copenhagen)
City
Copenhagen
ZIP/Postal Code
1159
Country
Denmark

12. IPD Sharing Statement

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Chronic Pain After Operation for Breast Cancer

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