Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

April 5, 2016 updated by: Kenneth Geving Andersen, Rigshospitalet, Denmark
The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain.

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.

Study Type

Observational

Enrollment (Actual)

545

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Rigshospitalet, Copenhagen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast cancer patients treated in a university hospital

Description

Inclusion Criteria:

  • Diagnosed with breast cancer
  • 18 years or older

Exclusion Criteria:

  • unable to give written consent
  • unable to understand Danish
  • Previous cosmetic surgery in the breast
  • Previous surgery in ipsilateral breast
  • Bilateral cancer
  • Concomitant corrective surgery on contralateral side
  • Pregnant
  • Other disease or injury in the nervous system
  • Psychiatric disease
  • Alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast cancer patients
Female breast cancer patients without metastasis and locally advanced disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors predisposing for persistent pain after breast cancer treatment
Time Frame: 12 months postoperative
Pre-, intra- and postoperative risk factors predisposing for persistent pain
12 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of persistent pain after breast cancer treatment
Time Frame: 12 months postoperative
12 months postoperative
Prevalence of sensory disturbances after breast cancer treatment
Time Frame: 12 months
12 months
Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve
Time Frame: 12 months
12 months
Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors
Time Frame: 12 months
12 months
Genetic markers and the development of persistent pain after breast cancer treatment
Time Frame: 12 months postoperative
12 months postoperative
QST profile 1 week after surgery for breast cancer
Time Frame: 1 week postoperative
Detailed QST profile 1 week after surgery for breast cancer. Patients will be assessed with sensory mapping, followed by assessment of mechanical and thermal thresholds.
1 week postoperative
Acute pain after surgery for breast cancer
Time Frame: 1 week postoperative
Prevalence of acute pain 1 week after surgery for breast cancer.
1 week postoperative
Test-Retest of QST after breast cancer treatment
Time Frame: 12 months postoperative
A test-retest series of a subgroup of patients assessed with QST, to evaluate methodological reliability. Patients are scheduled to 2 QST assessments with a week between.
12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Danish Cancer Society
Danish Breast Cancer Cooperative Group

Investigators

  • Principal Investigator: Kenneth Geving Andersen, MD, Rigshospitalet, Denmark
  • Study Chair: Henrik Kehlet, MD, PhD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2007-0098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe