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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00852111
First received: February 25, 2009
Last updated: June 25, 2014
Last verified: May 2014
  Purpose

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.

Condition
Cancer
Fatigue

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • The secondary outcomes of this study include: the proinflammatory cytokine profile of EBRT-related fatigue and white blood cell gene expression using buffy coat collection before, during, at completion and 4 weeks after EBRT completion.

Estimated Enrollment: 262
Study Start Date: February 2009
Detailed Description:

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 (SqrRoot) ) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • 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

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).

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852111

Contacts
Contact: Leorey N Saligan, C.R.N.P. (301) 451-1685 saliganl@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Leorey N Saligan, C.R.N.P. National Institute of Nursing Research (NINR)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00852111     History of Changes
Other Study ID Numbers: 090088, 09-NR-0088
Study First Received: February 25, 2009
Last Updated: June 25, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Fatigue
Radiotherapy
Cancer Therapy
Cancer

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014