Persistent Pain After Reconstruction Following Mastectomy

Breast Cancer Clinical Trial

Official title:

Persistent Pain After Reconstruction Following Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738048
• Other study ID #: H-D-2007-0099B
• Status: Completed
• Phase: N/A
• First received: November 22, 2012
• Last updated: November 29, 2012
• Start date: January 2008
• Est. completion date: April 2008

Study information

• Verified date: November 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Description:

The aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1352
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• recurrent cancer

• other malignancy

• emigration

• non-standardized treatment

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Breast Cancer Cooperative Group

Country where clinical trial is conducted

Denmark, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Prevalence of persistent pain after reconstruction after mastectomy	Self reported pain expressed as a percentage of the population of patients reconstructed with expander and autologous tissue. Pain intensity measured with a numerical rating scale 0-10, divided in mild (NRS 1-3), moderate (4-6) and severe pain (7-10). Patients regarded as having clinically relevant pain: NRS 4 or above, at least at a weekly basis.	Cross-sectional, 2-3 years after surgery for breast cancer	No
Secondary	Prevalence of sensory disturbances after reconstruction after mastectomy		Cross-sectional, 2-3 years after surgery for breast cancer	No