Status:
COMPLETED
Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy
Lead Sponsor:
National Institute of Nursing Research (NINR)
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Cancer
Fatigue
Eligibility:
MALE
18+ years
Brief Summary
Background: * 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...
Detailed Description
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 rela...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be included, patients must meet all of the following criteria:
- Clinically localized prostate cancer with or without prior prostatectomy;
- 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 ADT;
- No known medical history of tuberculosis (TB);
- Able to provide written informed consent by passing at least 80% of the consent quiz;
- Greater than or equal to18 years of age;
- The control group must meet all the inclusion criteria mentioned above except for number 2. The control group must not be receiving any form of treatment for their prostate cancer to include hormone, immune, radiation, or chemotherapy.
- EXCLUSION CRITERIA:
- All participants with any one of the following criteria will be excluded:
- Progressive or unstable disease of any body system causing 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, and cirrhosis).
- Patients taking tranquilizers, steroids, and nonsteroidal anti-inflammatory agents because these medications are known to affect cytokine production;
- Patients who have second malignancies or those receiving chemotherapy with their EBRT.
- In addition to the above criteria, participants with the following conditions will be excluded from participating in the exercise interventions:
- Significant Restrictive or Obstructive Lung Disease
- Ischemic heart disease
- Left ventricular dysfunction
- Acute corpulmonale
- Cardiomyopathy (dilated, hypertrophic, or non-idiopathic)
- Significant renal or hepatic dysfunction
- Disabling stroke
- Uncontrolled diabetes mellitus with a history of diabetic ketoacidosis
- Mitochondrial disease
- Participants unable to pass the English comprehension test will be unable to take the Computer Assessment of Mild Cognitive Impairement (CAMCT) test but will be asked to complete the other outcome measures of the study.
- Self report of color-blindness, verified by taking the Ishihara card test and scoring greater than 14 (more or less than 10 minutes), will exclude a participant from taking the STROOP test, but will be asked to complete the other outcome measures of the study. This card test will be administered only if the patient states they are color blind.
- \- Individuals capable of becoming pregnant.
Exclusion
Key Trial Info
Start Date :
April 23 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 24 2021
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00852111
Start Date
April 23 2009
End Date
August 24 2021
Last Update
March 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892