Study of Biological Markers and Clinical Correlates of 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.
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
|No phase specified||Biomarker/Laboratory analysis, Natural history/Epidemiology, Supportive care||Unknown||Not specified||Other||SGUL-PTF-Mechanisms|
PTF mechanisms, EU-20958, NCT00972400
- To investigate the relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition in breast cancer survivors.
- To identify and quantify serum biomarkers and underlying biological pathways unique to cancer-related fatigue syndrome in these survivors.
- To map changes over time in order to explore the inter-relationships between these variables.
- 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
- See Disease Characteristics
- Sufficient English language skills
- No significant cognitive impairment
- No concurrent severe combined immunodeficiency disease
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
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
|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|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.