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

18 Years
Open (Enrolling)
Cancer, Fatigue

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Trial Information

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

Although the underlying mechanisms of fatigue have been studied in several disease
conditions the data are not conclusive, and this symptom remains poorly managed at present.
Longitudinal studies related to treatment-related fatigue in prostate cancer patients have
been conducted, but there are limited studies exploring the changes in physiologic
mechanisms before and after radiotherapy which can identify individuals who are at risk for
enduring fatigue during and after therapy. Fatigue is conceptualized as a multidimensional
symptom which incorporates temporal, sensory, cognitive/mental, affective/emotional,
behavioral, and physiological dimensions.This prospective, observational study is the first
study to explore the molecular-genetic mechanisms underlying fatigue and the cluster of
symptoms (urinary, sexual, gastrointestinal, psychiatric) experienced by prostate cancer
patients undergoing External Beam Radiation Therapy (EBRT).

The primary objective of the study is to describe the changes in the self-reported fatigue;
urinary, sexual, and gastrointestinal symptoms; depression; fatigue catastrophizing; and
health-related quality of life (HRQOL) experienced by patients with and without prostate
surgery before, during, and after EBRT completion. The secondary objectives of this study
are to investigate the pro-inflammatory cytokine profile of EBRT-related fatigue (TNF?,
IGF-I, IL-6, IL-8, TGF? and (Beta)) and to determine changes in white blood cell gene
expression using buffy coat collection before, during, and after EBRT completion and to
relate these changes in the levels of these biological markers to self-reported fatigue;
urinary, sexual, and gastrointestinal symptoms; depression; fatigue catastrophizing; and
HRQOL scores. This study also aims to measure the skeletal muscle strength,
activity/fitness levels and energy expenditure of patients before, during, and at completion
of EBRT and relate these findings with self-reported fatigue, physical symptoms (e.g.
urinary, gastrointestinal, and sexual functioning), depression, and HRQOL scores before and
after an exercise training program. The study also aims to describe changes in chemical
profile in the brain that are associated with changes in fatigue symptoms using magnetic
resonance spectroscopy before and during EBRT.

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;

- 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.


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

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

Subjects will also be excluded from participating in the MRS pilot study if they have the
following conditions:

1. Patients with implanted cardiac pacemakers, metal aneurysm clips, or who have had
broken bones repaired with metal pins, screws, rods, plates, or those with prosthetic
eye implants, with transdermal medications or infusion pumps.

2. Patients with bullet fragments or other metal pieces in their body from old wounds.

3. Patients with significant work exposure to metal particles.

4. Patients with psychological contraindications for MRI (e.g. claustrophobia).

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

The primary outcomes of this study are self-reported fatigue, depression, and HRQOL of patients before, during, at completion, and 4 weeks after EBRT completion.

Principal Investigator

Leorey N Saligan, C.R.N.P.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Nursing Research (NINR)


United States: Federal Government

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Cancer
  • Fatigue
  • Fatigue
  • Radiotherapy
  • Cancer Therapy
  • Cancer
  • Fatigue



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892