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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

09-NR-0088

Sponsoring Institute

National Institute of Nursing Research (NINR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Female;
Children

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 Institute of Nursing Research

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.

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Eligibility

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;

- Men 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 with the ejection fraction less than 40 or a documented pulmonary capillary wedge pressure greater than or equal to 18mmHg.

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.


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Citations:

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.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leorey N. Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
BG 3 RM 5E14
3 CENTER DR
BETHESDA MD 20814
(301) 451-1685
saliganl@mail.nih.gov

Leorey N. Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
BG 3 RM 5E14
3 CENTER DR
BETHESDA MD 20814
(301) 451-1685
saliganl@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00852111

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