Relationship Between Mitochondrial Dysfunction and Fatique in Cancer Patients Following External Beam Radiation Therapy
Completed
Conditions studied: Cancer, Fatigue
In brief
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. More research is necessary to understand why patients receiving cancer treatment experience fatigue. Changes in mitochondria, parts of body cells that help provide energy to the cell, may contribute to fatigue. Researchers are interested in looking at blood chemicals and mitochondrial genes of cancer patients to study those associated with fatigue. Objectives: \- To study the relationship between fatigue and the effects of cancer treatment. Eligibility: * Men at least 18 years of age who have been diagnosed with localized prostate cancer and are scheduled to receive external beam radiation therapy. * Participants on study 09-NR-0088, Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving External Beam Radiation Therapy, are also eligible. Design: * This study requires three outpatient visits to the NIH Clinical Center. * Participants will be seen before they start radiation treatment, at the middle of treatment, and at the end of treatment. Each visit will take less than 30 minutes to complete. * Participants will complete questionnaires that ask about fatigue and depression. * Participants will provide blood samples for research testing and potential HIV testing. * No treatment will be provided as part of this protocol.
Key facts
- Study ID
- NCT01143467
- Run by
- National Institute of Nursing Research (NINR)
- People needed
- 26
- Starts
- 2010-05-24
- Expected to finish
- 2015-11-06
- Last updated by the study team
- 2017-10-06
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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