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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Danish Breast Cancer Cooperative Group
Danish Cancer Society
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01523132
First received: January 27, 2012
Last updated: August 28, 2014
Last verified: August 2014

January 27, 2012
August 28, 2014
November 2011
November 2014   (final data collection date for primary outcome measure)
Risk factors predisposing for persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]
Pre-, intra- and postoperative risk factors predisposing for persistent pain
Same as current
Complete list of historical versions of study NCT01523132 on ClinicalTrials.gov Archive Site
  • Prevalence of persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
  • Prevalence of sensory disturbances after breast cancer treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Genetic markers and the development of persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
  • QST profile 1 week after surgery for breast cancer [ Time Frame: 1 week postoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Prevalence of acute pain 1 week after surgery for breast cancer.
  • Test-Retest of QST after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
    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.
  • Prevalence of persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
  • Prevalence of sensory disturbances after breast cancer treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Genetic markers and the development of persistent pain after breast cancer treatment [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood

Probability Sample

Breast cancer patients treated in a university hospital

  • Breast Cancer
  • Persistent Pain
  • Lymphedema
  • Neuropathic Pain
  • Neuropathy
Not Provided
Breast cancer patients
Female breast cancer patients without metastasis and locally advanced disease
Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. Epub 2011 Mar 24. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
545
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01523132
H-D-2007-0098
Yes
Kenneth Geving Andersen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • Danish Breast Cancer Cooperative Group
  • Danish Cancer Society
Principal Investigator: Kenneth Geving Andersen, MD Rigshospitalet, Denmark
Study Chair: Henrik Kehlet, MD, PhD Rigshospitalet, Denmark
Rigshospitalet, Denmark
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP