Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Psychological and Social Factors That May Increase the Risk of Developing Chronic Pain After Surgery in Women With Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Natural history/Epidemiology Closed Over 18 Other IB-2005-31 INCA-RECF0143, IB-SDPM, IB2005-31, NCT00466830

Objectives

Primary

1. Determine the psychological and sociological factors that predispose post-mastectomy pain syndrome after surgery in women with resectable breast cancer.

Secondary

1. Determine the psychological and sociological factors that predispose post-surgical pain in these patients.
2. Evaluate emotional distress over time in these patients.
3. Evaluate the acute and chronic pain over time in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of breast cancer



• Mastectomy or lumpectomy, including axillary lymph node dissection, planned



• Analgesic fixed (or ordered) the morning of surgery
  • No stage III analgesic planned



• Hormone receptor status not specified

Prior/Concurrent Therapy:

• No recent major surgery
• No participation in another medical or surgical clinical trial in the past 30 days
• Prior breast surgery for a benign lesion or malignant lesion allowed

Patient Characteristics:

• Female
• Menopausal status not specified
• WHO performance status 0-2
• Other prior malignancy allowed
• No American Society of Anesthesiologists' class IV
• No contraindication or drug addiction
• No uncontrolled conditions, including any of the following:
  • Diabetes
  • Thyroid disease
  • Neuropsychiatric disease
  • Infection
  • Insufficient coronary function
  • NYHA class III-IV heart disease

Expected Enrollment

A total of 150 patients will be accrued for this study.

Outcomes

Development of post-mastectomy pain syndrome

Rate of post-surgical pain
Rate of emotional distress
Rate of acute and chronic pain

Outline

This is a multicenter study.

Patients complete multiple questionnaires, including Hospital Anxiety and Depression Scale (HAD), Maudsley Personality Inventory (MPI), PCS, and QLQ-C30, to evaluate psychological variables (alexithymia, neurosis, repression of negative emotions, solicitude, dramatization, emotional distress) and quality of life.

Post-mastectomy chronic pain (PMCP) syndrome is measured immediately after surgery and at 24 hours, day 6, and 5 months post-surgery.

A subgroup of patients (20 with PMCP and 20 without PMCP) are followed at months 5 and 6 months post-surgery for medication use, pathological problems, morbid events, family history, and environmental factors.

Trial Contact Information

Trial Lead Organizations

Institut Bergonie

Florence Dixmerias, MD, Protocol chair		Ph: 33-556-333-264

Registry Information
Official Title		Study of Psychological and Sociological Predisposing the Development of Chronic Pain After Surgery in Women With Resectable Breast Cancer
Trial Start Date		2005-09-26
Registered in ClinicalTrials.gov		NCT00466830
Date Submitted to PDQ		2007-03-22
Information Last Verified		2007-05-22

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