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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523132
First Posted: February 1, 2012
Last Update Posted: April 6, 2016
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.
Collaborators:
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark
  Purpose
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.

Condition
Breast Cancer Persistent Pain Lymphedema Neuropathic Pain Neuropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

Resource links provided by NLM:


Further study details as provided by Kenneth Geving Andersen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Prevalence of persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ]
  • Prevalence of sensory disturbances after breast cancer treatment [ Time Frame: 12 months ]
  • Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve [ Time Frame: 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 ]
  • Genetic markers and the development of persistent pain after breast cancer treatment [ Time Frame: 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.

  • Acute pain after surgery for breast cancer [ Time Frame: 1 week postoperative ]
    Prevalence of acute pain 1 week after surgery for breast cancer.

  • 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.


Biospecimen Retention:   Samples With DNA
blood

Enrollment: 545
Study Start Date: November 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer patients
Female breast cancer patients without metastasis and locally advanced disease

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast cancer patients treated in a university hospital
Criteria

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
  Contacts and Locations
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): NCT01523132


Locations
Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Investigators
Principal Investigator: Kenneth Geving Andersen, MD Rigshospitalet, Denmark
Study Chair: Henrik Kehlet, MD, PhD Rigshospitalet, Denmark
  More Information

Publications:
Responsible Party: Kenneth Geving Andersen, Physician, research fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01523132     History of Changes
Other Study ID Numbers: H-D-2007-0098
First Submitted: January 27, 2012
First Posted: February 1, 2012
Last Update Posted: April 6, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neuralgia
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lymphatic Diseases