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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523132
• Other study ID #: H-D-2007-0098
• Status: Completed
• Phase: N/A
• First received: January 27, 2012
• Last updated: April 5, 2016
• Start date: November 2011
• Est. completion date: November 2014

Study information

• Verified date: April 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Neuralgia
• Neuropathic Pain
• Neuropathy
• Persistent Pain

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Copenhagen University Hospital	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Breast Cancer Cooperative Group, Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

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. — View 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. — View 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):2413-22. doi: 10.1097/j.pain.0000000000000298. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors predisposing for persistent pain after breast cancer treatment	Pre-, intra- and postoperative risk factors predisposing for persistent pain	12 months postoperative	Yes
Secondary	Prevalence of persistent pain after breast cancer treatment		12 months postoperative	No
Secondary	Prevalence of sensory disturbances after breast cancer treatment		12 months	No
Secondary	Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve		12 months	Yes
Secondary	Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors		12 months	Yes
Secondary	Genetic markers and the development of persistent pain after breast cancer treatment		12 months postoperative	No
Secondary	QST profile 1 week after surgery for breast cancer	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	No
Secondary	Acute pain after surgery for breast cancer	Prevalence of acute pain 1 week after surgery for breast cancer.	1 week postoperative	No
Secondary	Test-Retest of QST after breast cancer treatment	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	No