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

NCT00852111 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 141

Last updated 2025-03-07

No results posted yet for this study

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • National Institute of Nursing Research (NINR)

    lead NIH

Principal Investigators

  • Leorey N Saligan, C.R.N.P. · National Institute of Nursing Research (NINR)

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-23
Primary Completion
2021-08-24
Completion
2021-08-24

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00852111 on ClinicalTrials.gov