Persistent Pain After Breast Cancer Treatment With Docetaxel

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01279018

Enrollment

2490

Registered

2011-01-19

Start date

2010-10-31

Completion date

2011-01-31

Last updated

2011-01-19

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

Conditions

Breast Neoplasms, Lymphedema, Neuralgia, Pain, Postoperative

Keywords

Persistent postsurgical pain, breast cancer, postmastectomy pain syndrome, neuropathic pain

Brief summary

Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Inclusion criteria

* Treated for primary breast cancer in Denmark 2007-2008 * Age between 18-80 years * No recurrent cancer * Female

Exclusion criteria

* Previous breast surgery same side (including plastic and reconstructive surgery) * Bilateral breast surgery * Recurrent cancer or metastatic cancer

Design outcomes

Primary

Measure	Time frame
Docetaxel as a risk factor for development of persistent pain	Between 2-3 years post surgery

Secondary

Measure	Time frame
Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations	Between 2-3 years post surgery

Outcome results