Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy


Condition: Cancer, Fatigue

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00852111

Sponsor: National Institute of Nursing Research (NINR)

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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: 1. Significant Restrictive or Obstructive Lung Disease 2. Ischemic heart disease 3. Left ventricular dysfunction 4. Acute corpulmonale 5. Cardiomyopathy (dilated, hypertrophic, or non-idiopathic) 6. Significant renal or hepatic dysfunction 7. Disabling stroke 8. Uncontrolled diabetes mellitus with a history of diabetic ketoacidosis 9. 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.

View trial on ClinicalTrials.gov