Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment
|First Received Date ICMJE||October 29, 2010|
|Last Updated Date||May 23, 2013|
|Start Date ICMJE||October 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary outcomes of this study are self-reported fatigue, depression, and quality of life scores of patients before, at midpoint, and at completion of each cycle of their cancer treatment.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01231932 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment|
|Official Title ICMJE||Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment|
- Fatigue, a common side effect of cancer and its treatment, is found in up to 96% of cancer patients. Fatigue is difficult to treat because its cause is poorly understood. Research has indicated that cancer-related fatigue may be caused by a number of factors, including immune system responses to cancer treatment. Researchers are interested in studying individuals who are receiving cancer treatment in order to better understand the causes of fatigue.
- To study fatigue in individuals who are receiving cancer treatment.
- Individuals at least 18 years of age who have localized cancer that has not spread and are scheduled to start cancer treatment at the National Institutes of Health.
Although the underlying mechanisms of fatigue have been studied in several disease conditions, the etiology, mechanisms, and risk factors remain elusive, and this symptom remains poorly managed at present. Longitudinal studies related to treatment-related fatigue in cancer patients have been conducted, but there are limited data showing changes in molecular mechanisms before and after cancer therapy which can identify individuals who are at risk to experience 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 will explore the molecular-genetic mechanisms underlying fatigue experienced by cancer patients receiving various therapies (e.g. immune therapy, hormone therapy, and chemotherapy).
The primary objective of the study is to describe the changes in the self-reported fatigue, depression, and health-related quality of life (HRQOL) experienced by cancer patients before, during, and after cancer therapy. The secondary objectives of this study are to investigate the pro-inflammatory cytokine profile (TNFalpha, IGF-I, IL-6, IL-8, TGFalpha and beta), determine changes in gene expression from peripheral blood and tissue samples before, during, and after cancer treatment and to relate changes in the levels of these biological markers to self-reported fatigue, depression, and HRQOL scores. This study also aims to measure the skeletal muscle strength, cognitive function, activity levels and energy expenditure of patients before, during, and at completion of cancer treatment and relate these findings with self-reported fatigue, depression, and HRQOL scores.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||90|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01231932|
|Other Study ID Numbers ICMJE||110014, 11-NR-0014|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Nursing Research (NINR)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP