NCT01523132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

January 27, 2012

Last Update Submit

April 5, 2016

Conditions

Breast CancerPersistent PainLymphedemaNeuropathic PainNeuropathy

Outcome Measures

Primary Outcomes (1)

  • Risk factors predisposing for persistent pain after breast cancer treatment

    Pre-, intra- and postoperative risk factors predisposing for persistent pain

    12 months postoperative

Secondary Outcomes (8)

  • Prevalence of persistent pain after breast cancer treatment

    12 months postoperative

  • Prevalence of sensory disturbances after breast cancer treatment

    12 months

  • Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve

    12 months

  • Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors

    12 months

  • Genetic markers and the development of persistent pain after breast cancer treatment

    12 months postoperative

  • +3 more secondary outcomes

Study Arms (1)

Breast cancer patients

Female breast cancer patients without metastasis and locally advanced disease

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Breast cancer patients treated in a university hospital

You may qualify if:

  • Diagnosed with breast cancer
  • years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 21435953BACKGROUND

  • 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.

    PMID: 26176893RESULT

  • 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.

    PMID: 25084072RESULT

  • 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.

    PMID: 26446738RESULT

  • 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.

    PMID: 25307709RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Breast NeoplasmsLymphedemaNeuralgia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kenneth Geving Andersen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Henrik Kehlet, MD, PhD

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, research fellow

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 1, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

DK(1)