Cancer Clinical Trial
Official title:
Relationship Between Mitochondrial Dysfunction and Fatique in Cancer Patients Following External Beam Radiation Therapy
Verified date | November 6, 2015 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | November 6, 2015 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 100 Years |
Eligibility |
- INCLUSION CRITERIA: 1. Clinically localized prostate cancer; 2. 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); 3. Able to provide written informed consent; 4. Men greater than or equal to 18 years of age; 5. 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: 1. Systemic infections (e.g., human immunodeficiency virus [HIV], active hepatitis); 2. Documented history of major depression, bipolar disease, psychosis, or alcohol dependence/abuse within the past 5 years; 3. Uncorrected hypothyroidism and anemia; 4. 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Nursing Research (NINR) |
United States,
Cheville AL. Cancer-related fatigue. Phys Med Rehabil Clin N Am. 2009 May;20(2):405-16. doi: 10.1016/j.pmr.2008.12.005. Review. — View Citation
Greenberger JS. Radioprotection. In Vivo. 2009 Mar-Apr;23(2):323-36. Review. — View Citation
Lemle MD. Hypothesis: chronic fatigue syndrome is caused by dysregulation of hydrogen sulfide metabolism. Med Hypotheses. 2009 Jan;72(1):108-9. doi: 10.1016/j.mehy.2008.08.003. Epub 2008 Sep 16. — View Citation
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