Relationship Between Mitochondrial Dysfunction and Fatique in Cancer Patients Following External Beam Radiation Therapy

NCT01143467 | Completed

• 2 other identifiers: 10012810-NR-0128
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Cancer; Fatigue

Keywords

Fatigue; Mitochondria; Mitochondrial Abnormality; Oxidative Stress; Gene Expression; Prostate Cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. No abstract available.

  PMID: 18799269 BACKGROUND

• Greenberger JS. Radioprotection. In Vivo. 2009 Mar-Apr;23(2):323-36.

  PMID: 19414422 BACKGROUND

• 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.

  PMID: 19389620 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Fatigue; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Leorey N Saligan, C.R.N.P.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: May 24, 2010
• Study Completion: November 6, 2015
• Last Updated: October 6, 2017

Record last verified: 2015-11-06

Locations

US (1)