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

Alternate Title

Fatigue in Breast Cancer Survivors. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

Objectives

1. To investigate the relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition in breast cancer survivors.
2. To identify and quantify serum biomarkers and underlying biological pathways unique to cancer-related fatigue syndrome in these survivors.
3. To map changes over time in order to explore the inter-relationships between these variables.

Entry Criteria

Disease Characteristics:

• Disease-free breast cancer survivors between 3 months and 2 years after completion of primary treatment

• Recruited from the nurse-led breast cancer follow-up clinic at St George’s Hospital

Prior/Concurrent Therapy:

• See Disease Characteristics

Patient Characteristics:

• Sufficient English language skills
• No significant cognitive impairment
• No concurrent severe combined immunodeficiency disease

Expected Enrollment

Outcomes

Relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition
Identification and quantification of serum biomarkers underlying biological pathways unique to cancer-related fatigue syndrome
Inter-relationships between variables

Outline

Participants undergo fatigue assessment by the Diagnostic Interview for Cancer Related Fatigue and the FACT-Fatigue questionnaire; psychological symptoms assessment by the Structured Clinical Interview for DSM-IV, Hospital Anxiety and Depression Scale, and the Insomnia Severity Index questionnaires; and quality of life assessment by the EORTC-QLQc30 and EORTC-QLQ-BR23 questionnaires twice approximately 3 months apart.

Participants also undergo activity level, circadian rhythm, and sleep measurements by the Micro-mini® Motionlogger actigraphy and measurement of cognitive disturbances by the Cantabeclipse™ technology.

Participants undergo blood sample collection for protein analysis by 2D gel electrophoresis and mass spectrometry.

Trial Contact Information

Trial Lead Organizations

St. Georges, University of London

Ollie Minton, MD, Principal investigator		Ph: 44-2087-252-620

United Kingdom
England
	London
	St. Georges, University of London
		Ollie Minton, MD	Ph:  44-2087-252-620

Registry Information
Official Title		Biological mechanisms of fatigue in breast cancer survivors
Trial Start Date		2009-01-05
Trial Completion Date		2011-01-01 (estimated)
Registered in ClinicalTrials.gov		NCT00972400
Date Submitted to PDQ		2009-06-17
Information Last Verified		2009-09-02

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