Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy
Although the underlying mechanisms of fatigue have been studied in several disease
conditions the data are not conclusive, and this symptom remains poorly managed at present.
Longitudinal studies related to treatment-related fatigue in prostate cancer patients have
been conducted, but there are limited studies exploring the changes in physiologic
mechanisms before and after radiotherapy which can identify individuals who are at risk for
enduring fatigue during and after therapy. Fatigue is conceptualized as a multidimensional
symptom which incorporates temporal, sensory, cognitive/mental, affective/emotional,
behavioral, and physiological dimensions.This prospective, observational study is the first
study to explore the molecular-genetic mechanisms underlying fatigue and the cluster of
symptoms (urinary, sexual, gastrointestinal, psychiatric) experienced by prostate cancer
patients undergoing External Beam Radiation Therapy (EBRT).
The primary objective of the study is to describe the changes in the self-reported fatigue;
urinary, sexual, and gastrointestinal symptoms; depression; fatigue catastrophizing; and
health-related quality of life (HRQOL) experienced by patients with and without prostate
surgery before, during, and after EBRT completion. The secondary objectives of this study
are to investigate the pro-inflammatory cytokine profile of EBRT-related fatigue (TNF?,
IGF-I, IL-6, IL-8, TGF? and (Beta)) and to determine changes in white blood cell gene
expression using buffy coat collection before, during, and after EBRT completion and to
relate these changes in the levels of these biological markers to self-reported fatigue;
urinary, sexual, and gastrointestinal symptoms; depression; fatigue catastrophizing; and
HRQOL scores. This study also aims to measure the skeletal muscle strength,
activity/fitness levels and energy expenditure of patients before, during, and at completion
of EBRT and relate these findings with self-reported fatigue, physical symptoms (e.g.
urinary, gastrointestinal, and sexual functioning), depression, and HRQOL scores before and
after an exercise training program. The study also aims to describe changes in chemical
profile in the brain that are associated with changes in fatigue symptoms using magnetic
resonance spectroscopy before and during EBRT.
Observational
Time Perspective: Prospective
The primary outcomes of this study are self-reported fatigue, depression, and HRQOL of patients before, during, at completion, and 4 weeks after EBRT completion.
Leorey N Saligan, C.R.N.P.
Principal Investigator
National Institute of Nursing Research (NINR)
United States: Federal Government
090088
NCT00852111
February 2009
Name | Location |
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National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |