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Trial record 1 of 1 for:    NCT01231932
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Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment

This study is currently recruiting participants.
Verified May 9, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01231932
First Posted: November 1, 2010
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
  Purpose

Background:

- 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.

Objectives:

- To study fatigue in individuals who are receiving cancer treatment.

Eligibility:

- 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.

Design:

  • This study involves an initial screening visit and a minimum of three outpatient visits.
  • Participants will be screened with a medical history, and blood tests.
  • Participants who are scheduled to have cycles of cancer treatment will be seen once before the start of each cycle, once at the midpoint of each cycle, and once at the end of each cycle. Participants whose treatment does not follow a cycle will be seen before the start of treatment; 2 weeks after starting treatment; and 1 month, 3 months, 6 months, and 1 year after starting treatment, for a total of six outpatient visits.
  • At each study visit, participants will complete the following tasks:
  • Questionnaires about physical activity, fatigue, depression, and quality of life.
  • Computerized cognitive tests of memory, attention, and ability to follow directions. The tests are timed to determine whether these brain functions are affected by cancer treatment and whether they occur with fatigue symptoms.
  • Blood samples to monitor immune system and other responses to treatment.
  • Hand grip strength test to evaluate physical strength.
  • Physical activity monitor and journals to study how fatigue affects physical activity.
  • Participants who need additional cycles of cancer treatment will continue to have visits until the end of the third cycle, for a maximum of nine outpatient visits.
  • Treatment will not be provided under this study.

Condition
Cancer Fatigue

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) ):

Primary Outcome Measures:
  • 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. [ Time Frame: Before and after completion of cancer therapy either in cyclic or non-cyclic regimens ]

Secondary Outcome Measures:
  • White blood cell gene expression [ Time Frame: Before and after completion of cancer therapy either in cyclic or non-cyclic regimens ]
  • Fatigue, cognitive function, and HRQOL scores [ Time Frame: Before and after completion of cancer therapy either in cyclic or non-cyclic regimens ]
  • Physical activity levels [ Time Frame: Before and after completion of cancer therapy either in cyclic or non-cyclic regimens ]
  • Skeletal muscle strength [ Time Frame: Before and after completion of cancer therapy either in cyclic or non-cyclic regimens ]

Estimated Enrollment: 206
Study Start Date: October 29, 2010
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  • Fluent in one of the languages listed in Appendix 2 of protocol.

EXCLUSION CRITERIA:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231932


Contacts
Contact: Leorey N Saligan, C.R.N.P. (301) 451-1685 saliganl@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Leorey N Saligan, C.R.N.P. National Institute of Nursing Research (NINR)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT01231932     History of Changes
Other Study ID Numbers: 110014
11-NR-0014
First Submitted: October 29, 2010
First Posted: November 1, 2010
Last Update Posted: October 19, 2017
Last Verified: May 9, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) ):
Fatigue
Cancer
Cancer Therapy
Cancer Treatment
Gene Expression Patterns

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms