Fatigue in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Biological Mechanisms of Fatigue in Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00972400
• Other study ID #: CDR0000647658
• Secondary ID: SGUL-PTF-Mechani
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2009
• Last updated: August 23, 2013
• Start date: January 2009

Study information

• Verified date: September 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

RATIONALE: Gathering information over time from blood samples and measurements of activity, sleep, mood, and cognition may help doctors learn more about fatigue in breast cancer survivors and plan the best treatment.

PURPOSE: This clinical trial is studying fatigue in breast cancer survivors.

Description:

OBJECTIVES:

• 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

PATIENT CHARACTERISTICS:

• Sufficient English language skills

• No significant cognitive impairment

• No concurrent severe combined immunodeficiency disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivor
• Fatigue
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Genetic:
• protein analysis

Other:
• laboratory biomarker analysis

• mass spectrometry

• questionnaire administration

Procedure:
• assessment of therapy complications

• cognitive assessment

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	St. Georges, University of London	London	England

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition			No
Primary	Identification and quantification of serum biomarkers underlying biological pathways unique to cancer-related fatigue syndrome			No
Primary	Inter-relationships between variables			No