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

NCT00852111 | Completed

• 2 other identifiers: 09008809-NR-0088
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Fatigue

Keywords

Fatigue; Radiotherapy; Cancer Therapy; Natural History; Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Score measured by PROMIS-Fatigue scale

  Ongoing

Secondary Outcomes (1)

• Change in gene expression, cytokine profile, skeletal muscle strength, cognitive function

  Ongoing

Study Arms (1)

Patients

Prostate cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This protocol will enroll 262 men with prostate cancer, 161 (116 without prior prostatectomy and 45 with previous prostatectomy) who are scheduled to receive EBRT. Additional 56 men will be invited to participate in 8-week, an hour/day, 3 days/week aerobic exercise programs (CT \[N=28\], HIIT \[N=28\]). It will also enroll 45 men with prostate cancer who are not currently receiving any treatment to serve as the control group for the study. Ten additional prostate cancer subjects (with and without previous prostatectomy) who are scheduled to be treated with EBRT will also be enrolled for the pilot study subgroup to determine associations between fatigue with structural and chemical changes of the brain using magnetic resonance spectrospcopy (MRS). Thirty additional men (with and without previous prostatectomy) will be enrolled for the pilot study subgroup to collect buccal swabs to measure proteins related to mitochondrial function. The study will enroll a total of 262 subjects.

You may qualify if:

• 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;
• Greater than or equal to18 years of age;

You may not qualify if:

• 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:
• Significant Restrictive or Obstructive Lung Disease
• Ischemic heart disease
• Left ventricular dysfunction
• Acute corpulmonale
• Cardiomyopathy (dilated, hypertrophic, or non-idiopathic)
• Significant renal or hepatic dysfunction

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leorey N Saligan, C.R.N.P.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: April 23, 2009
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

US (1)