Status:
COMPLETED
Relationship Between Mitochondrial Dysfunction and Fatique in Cancer Patients Following External Beam Radiation Therapy
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Cancer
Fatigue
Eligibility:
MALE
18-100 years
Brief Summary
Background: \- Fatigue is a very common early and late side effect of cancer treatment, including radiation therapy. The cause of fatigue is poorly understood, making it hard to diagnose and treat. M...
Detailed Description
Fatigue is a common early and chronic adverse effect of radiation but its correlates and prevalence are poorly understood. Over 40% of cancer patients receive radiation therapy during the management o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Clinically localized prostate cancer;
- Scheduled to receive EBRT either by 3D conformal or IMRT techniques that is not anticipated to change during the course of the study, with or without Androgen Deprivation Therapy (ADT);
- Able to provide written informed consent;
- Men greater than or equal to 18 years of age;
- Have enrolled in the study of molecular-genetic correlates of fatigue in cancer patients receiving localized radiation therapy (09-NR-0088).
- EXCLUSION CRITERIA:
- A. Any condition other than prostate cancer able to cause clinically significant fatigue including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal, or immunologic disorders, and including patients with any of the following broad disease categories:
- Systemic infections (e.g., human immunodeficiency virus \[HIV\], active hepatitis);
- Documented history of major depression, bipolar disease, psychosis, or alcohol dependence/abuse within the past 5 years;
- Uncorrected hypothyroidism and anemia;
- Chronic inflammatory disease that may be anticipated to alter the proinflammatory cytokine profile (i.e. rheumatoid arthritis, systemic lupus erythematosus, cirrhosis).
- B. Patients taking tranquilizers, steroids, and nonsteroidal anti-inflammatory agents because these medications are known to affect cytokine production;
- C. Patients who have second malignancies or those receiving chemotherapy with their EBRT.
Exclusion
Key Trial Info
Start Date :
May 24 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 6 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01143467
Start Date
May 24 2010
End Date
November 6 2015
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892