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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01543711

Enrollment

2411

Registered

2012-03-05

Start date

2012-01-31

Completion date

2012-04-30

Last updated

2013-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lymphedema, Neuropathy, Pain, Post Operative Pain

Keywords

Breast cancer, persistent pain, neuropathic pain, lymphedema

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Denmark

Outcome results