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Clinical Trials (PDQ®)

  • First Published: 9/2/2009

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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.

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

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Natural history/Epidemiology, Supportive careUnknownNot specifiedOtherSGUL-PTF-Mechanisms
PTF mechanisms, EU-20958, NCT00972400

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

96

Outcomes

Primary Outcome(s)

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

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

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.

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