Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00852111|
Recruitment Status : Recruiting
First Posted : February 26, 2009
Last Update Posted : August 9, 2018
- Researchers have studied the causes of fatigue during treatments for various diseases, but these results have not been conclusive.
- More information on the physical changes that affect the body during treatment may help identify biological or chemical factors that contribute to patient fatigue, which may allow physicians to identify individuals who may be more at risk of feeling fatigue before, during, and after treatment for diseases such as cancer.
- To identify factors contributing to fatigue in men who are undergoing radiation treatment for prostate cancer.
- Men 18 years of age and older who are scheduled to receive localized radiation treatment for prostate cancer.
- Six outpatient visits to the NIH Clinical Center, approximately on the same day and same time of day:
- First visit before beginning radiation treatment.
- Once a week for the first 2 weeks of the treatment, once at the midpoint of treatment, once at the end of treatment.
- Final visit 4 weeks after completion of radiation treatment.
- Initial visit will involve a physical examination and questions about medical history.
- Evaluations during the treatment period:
- Blood draws to identify cells and chemicals associated with inflammation and fatigue.
- Questions about physical activity, fatigue, depression, and quality of life.
|Condition or disease|
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 alpha, IGF-I, IL-6, IL-8, TGF alpha and beta), determine changes in white blood cell gene expression, determine levels of oxidative stress and changes in potential biomarkers influencing oxidative stress from blood and buccal 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, cognitive function and energy expenditure of patients before, at completion of EBRT, and at least 6 months post 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 after EBRT.
|Study Type :||Observational|
|Estimated Enrollment :||262 participants|
|Official Title:||Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy|
|Study Start Date :||February 24, 2009|
- 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.
- The secondary outcomes of this study include: the proinflammatory cytokine profile of EBRT-related fatigue and white blood cell gene expression using buffy coat collection before, during, at completion and 4 weeks after EBRT completion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852111
|Contact: Leorey N Saligan, C.R.N.P.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Leorey N Saligan, C.R.N.P.||National Institute of Nursing Research (NINR)|