Protocol Number: 09-NR-0088

Title:

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

Number:

09-NR-0088

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 the body during treatment may help identify biological or chemical factors that contribute to patient fatigue, which may allow physicians to identify individuals who may be more at risk of feeling fatigue before, during, and after treatment for diseases such as cancer.

Objectives:

- To identify factors contributing to fatigue in men who are undergoing radiation treatment for prostate cancer.

Eligibility:

- Men 18 years of age and older who are scheduled to receive localized radiation treatment for prostate cancer.

Design:

- Six outpatient visits to the NIH Clinical Center, approximately on the same day and same time of day:

- First visit before beginning radiation treatment.

- Once a week for the first 2 weeks of the treatment, once at the midpoint of treatment, once at the end of treatment.

- Final visit 4 weeks after completion of radiation treatment.

- Initial visit will involve a physical examination and questions about medical history.

- Evaluations during the treatment period:

- Blood draws to identify cells and chemicals associated with inflammation and fatigue.

- Questions about physical activity, fatigue, depression, and quality of life.

Sponsoring Institute:

National Institute of Nursing Research (NINR)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male

Referral Letter Required: Yes

Population Exclusion(s): Female

Children

Eligibility Criteria:

INCLUSION CRITERIA:

To be included, patients must meet all of the following criteria:

- 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 ADT;

- No known medical history of tuberculosis (TB);

- Able to provide written informed consent;

- Men greater than or equal to18 years of age;

EXCLUSION CRITERIA:

Patients 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, 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.

Special Instructions:

Currently Not Provided

Keywords:

Fatigue

Radiotherapy

Cancer Therapy

Recruitment Keyword(s):

Cancer

Fatigue

Condition(s):

Cancer

Fatigue

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institutes of Nursing Research

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Bower JE, Ganz PA, Aziz N, Fahey JL. Fatigue and proinflammatory cytokine activity in breast cancer survivors. Psychosom Med. 2002 Jul-Aug;64(4):604-11.

Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]Neurol Neurochir Pol. 2007 Jul-Aug;41(4):340-9. Review. Polish.

Miaskowski C, Paul SM, Cooper BA, Lee K, Dodd M, West C, Aouizerat BE, Swift PS, Wara W. Trajectories of fatigue in men with prostate cancer before, during, and after radiation therapy.J Pain Symptom Manage. 2008 Jun;35(6):632-43. Epub 2008 Mar 20.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 11/25/2009