Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00852111|
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : January 5, 2022
|First Submitted Date||February 25, 2009|
|First Posted Date||February 26, 2009|
|Last Update Posted Date||January 5, 2022|
|Actual Study Start Date||April 23, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Change in Fatigue Score measured by PROMIS-Fatigue scale [ Time Frame: Ongoing ]|
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures
||Change in gene expression, cytokine profile, skeletal muscle strength, cognitive function [ Time Frame: Ongoing ]|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy|
|Official Title||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 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.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|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.|
Prostate cancer patients
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
To be included, patients must meet all of the following criteria:
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:
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:
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.
Self report of color-blindness, verified by taking the Ishihara card test and scoring greater than 14 (more or less than 10 minutes), will exclude a participant from taking the STROOP test, but will be asked to complete the other outcome measures of the study. This card test will be administered only if the patient states they are color blind.
- Individuals capable of becoming pregnant.
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||090088
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )|
|Study Sponsor||National Institute of Nursing Research (NINR)|
|Collaborators||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 30, 2021|