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NCT Number: NCT01523132

Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Neuropathy Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Persistent Pain Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rigshospitalet, Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

About this study

The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with breast cancer
  • 18 years or older

Exclusion criteria

  • unable to give written consent
  • unable to understand Danish
  • Previous cosmetic surgery in the breast
  • Previous surgery in ipsilateral breast
  • Bilateral cancer
  • Concomitant corrective surgery on contralateral side
  • Pregnant
  • Other disease or injury in the nervous system
  • Psychiatric disease
  • Alcohol or drug abuse

Treatment and study plan

Primary outcomes

  1. Risk factors predisposing for persistent pain after breast cancer treatment

    Time frame: 12 months postoperative

    Pre-, intra- and postoperative risk factors predisposing for persistent pain

Secondary outcomes

  1. Prevalence of persistent pain after breast cancer treatment

    Time frame: 12 months postoperative

  2. Prevalence of sensory disturbances after breast cancer treatment

    Time frame: 12 months

  3. Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve

    Time frame: 12 months

  4. Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors

    Time frame: 12 months

  5. Genetic markers and the development of persistent pain after breast cancer treatment

    Time frame: 12 months postoperative

  6. QST profile 1 week after surgery for breast cancer

    Time frame: 1 week postoperative

    Detailed QST profile 1 week after surgery for breast cancer. Patients will be assessed with sensory mapping, followed by assessment of mechanical and thermal thresholds.

  7. Acute pain after surgery for breast cancer

    Time frame: 1 week postoperative

    Prevalence of acute pain 1 week after surgery for breast cancer.

  8. Test-Retest of QST after breast cancer treatment

    Time frame: 12 months postoperative

    A test-retest series of a subgroup of patients assessed with QST, to evaluate methodological reliability. Patients are scheduled to 2 QST assessments with a week between.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Breast Cancer Cooperative Group
  • Danish Cancer Society

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2012
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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