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

NCT ID: NCT01523132

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

545 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Persistent Pain Lymphedema Neuropathic Pain Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer patients

Female breast cancer patients without metastasis and locally advanced disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Danish Breast Cancer Cooperative Group

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Geving Andersen

Physician, research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Geving Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Henrik Kehlet, MD, PhD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 21435953 (View on PubMed)

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.

Reference Type RESULT
PMID: 26176893 (View on PubMed)

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.

Reference Type RESULT
PMID: 25084072 (View on PubMed)

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.

Reference Type RESULT
PMID: 26446738 (View on PubMed)

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.

Reference Type RESULT
PMID: 25307709 (View on PubMed)

Other Identifiers

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H-D-2007-0098

Identifier Type: -

Identifier Source: org_study_id

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