NCT01738048

Brief Summary

A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,352

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 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

January 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

3 months

First QC Date

November 22, 2012

Last Update Submit

November 29, 2012

Conditions

Breast CancerChronic Pain

Keywords

PainNeuropathic painChronic pain

Outcome Measures

Primary Outcomes (1)

  • The risk of developing persistent if reconstructed

    The risk of developing persistent if reconstructed compared to patients mastectomized without reconstruction expressed as an odds ratio.

    Cross-sectional, 2-3 years after surgery for breast cancer

Secondary Outcomes (2)

  • Prevalence of persistent pain after reconstruction after mastectomy

    Cross-sectional, 2-3 years after surgery for breast cancer

  • Prevalence of sensory disturbances after reconstruction after mastectomy

    Cross-sectional, 2-3 years after surgery for breast cancer

Study Arms (2)

Mastectomy

Patients treated with mastectomy without reconstruction

Reconstruction

Patients treated with mastectomy followed by reconstruction

Procedure: Reconstruction

Interventions

ReconstructionPROCEDURE

Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction

Reconstruction

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Nationwide cross-sectional cohort

You may qualify if:

  • Patients with unilateral primary breast cancer aged 18-70 years

You may not qualify if:

  • recurrent cancer
  • other malignancy
  • emigration
  • non-standardized treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Breast NeoplasmsChronic PainPainNeuralgia

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Kenneth G Andersen, MD

    Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, research fellow

Study Record Dates

First Submitted

November 22, 2012

First Posted

November 30, 2012

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

DK(1)