Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00852111 |
Other study ID # |
090088 |
Secondary ID |
09-NR-0088 |
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 23, 2009 |
Study information
Verified date |
March 22, 2024 |
Source |
National Institutes of Health Clinical Center (CC) |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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 alpha,
IGF-I, IL-6, IL-8, TGF alpha and beta), determine changes in white blood cell gene
expression, determine levels of oxidative stress and changes in potential biomarkers
influencing oxidative stress from blood and buccal samples before 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, cognitive function and energy expenditure of patients before, at
completion of EBRT, and at least 6 months post 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 after EBRT.