Clinical trial NCT01523132: Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
Official title: Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Persistent Pain
Lymphedema
Neuropathic Pain
Neuropathy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Breast Cancer Cooperative Group
name: Danish Cancer Society
First posted: 2012-02-01
Enrollment: 545
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients treated in a university hospital

Brief summary: 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.

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 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

Primary outcomes:
measure: Risk factors predisposing for persistent pain after breast cancer treatment
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Prevalence of persistent pain after breast cancer treatment
timeFrame: 12 months postoperative
measure: Prevalence of sensory disturbances after breast cancer treatment
timeFrame: 12 months
measure: Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve
timeFrame: 12 months
measure: Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors
timeFrame: 12 months
measure: Genetic markers and the development of persistent pain after breast cancer treatment
timeFrame: 12 months postoperative
measure: QST profile 1 week after surgery for breast cancer
timeFrame: 1 week postoperative
measure: Acute pain after surgery for breast cancer
timeFrame: 1 week postoperative
measure: Test-Retest of QST after breast cancer treatment
timeFrame: 12 months postoperative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kenneth Geving Andersen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, MD, PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
citation: Andersen KG, Duriaud HM, Jensen HE, Kroman N, Kehlet H. Predictive factors for the development of persistent pain after breast cancer surgery. Pain. 2015 Dec;156(12):2413-2422. doi: 10.1097/j.pain.0000000000000298.
citation: Andersen KG, Kehlet H, Aasvang EK. Test-retest agreement and reliability of quantitative sensory testing 1 year after breast cancer surgery. Clin J Pain. 2015 May;31(5):393-403. doi: 10.1097/AJP.0000000000000136.
citation: Andersen KG, Duriaud HM, Aasvang EK, Kehlet H. Association between sensory dysfunction and pain 1 week after breast cancer surgery: a psychophysical study. Acta Anaesthesiol Scand. 2016 Feb;60(2):259-69. doi: 10.1111/aas.12641. Epub 2015 Oct 8.
citation: Andersen KG, Aasvang EK, Kroman N, Kehlet H. Intercostobrachial nerve handling and pain after axillary lymph node dissection for breast cancer. Acta Anaesthesiol Scand. 2014 Nov;58(10):1240-8. doi: 10.1111/aas.12393.