Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment

Completed

• Conditions: Breast Cancer; Pain; Post Operative Pain; Lymphedema; Neuropathy

• Registration Number: NCT01543711
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. The investigators have previously published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006. Very few studies have examined how these late effects change in time. The aim of this study is to examine in a well defined patient population any change in the prevalence of persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-05
• Last Update Posted: 2013-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2411

Inclusion Criteria

• Diagnosed with primary breast cancer between 2005-2006
• Participated in a study in 2008

Exclusion Criteria

• Recurrent or new primary cancer
• Metastatic cancer
• Reconstructive surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of persistent pain	6-7 years post operative	Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable
Prevalence of patients changing pain status from the 2008 survey	6-7 years

Secondary Outcome Measures

Name	Time	Method
Prevalence of functional impairment	6-7 years
Prevalence of self reported lymphedma	6-7 years
Prevalence of sensory disturbance	6-7 years
Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment	6-7 years
Prevalence of patients changing status of sensory disturbances and self reported lymphedma	6-7 years
Risk factors associated to changing status of sensory disturbances and lymphedema	6-7 years post operative

Trial Locations

Locations (1)

Rigshospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark