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Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment

18 Years
Open (Enrolling)
Cancer, Fatigue

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Trial Information

Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment

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.

Inclusion Criteria


- Clinically localized or metastatic cancer as determined by diagnostic testing such as
cytology and imaging (such as, but not limited to non-metastatic head and neck
cancer, lung cancer, breast cancer, renal cancer)

- Scheduled to receive primary cancer treatment or salvage therapy (e.g. hormone
therapy, chemotherapy plus glucocorticosteroids, immunotherapy or a combination of
cancer treatments), and the type/s of treatment is not anticipated to change during
the course of the study

- Able to provide written informed consent

- Women and men greater than or equal to18 years of age.


- Progressive or unstable disease other than cancer of any body system causing
clinically significant fatigue (e.g. class IV congestive heart failure, end-stage
renal disease, stage IV chronic obstructive pulmonary disease) including patients
with systemic infections (e.g., human immunodeficiency virus [HIV], active
hepatitis); documented recent (< 5 years) history of major depression, bipolar
disease, psychosis, or alcohol/drug dependence/abuse; uncorrected hypothyroidism,
untreated anemia; and those with chronic inflammatory disease (e.g. rheumatoid
arthritis, systemic lupus erythematosus).

- Patients regularly taking antipsychotics, and anticonvulsants, since these
medications cause significant fatigue

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

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.

Principal Investigator

Leorey N Saligan, C.R.N.P.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Nursing Research (NINR)


United States: Federal Government

Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Cancer
  • Fatigue
  • Fatigue
  • Cancer
  • Cancer Therapy
  • Cancer Treatment
  • Gene Expression Patterns
  • Fatigue



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892