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

Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

- 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. - NIH employees and staff are eligible to participate. 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 - Self-report of color-blindness, verified by taking the Ishihara card test with scores >14 (approximately 10 minutes), will be excluded from taking the STROOP test, but will be asked to complete the other study outcomes. This card test will be administered only if the patient reports being color blind.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cancer

Fatigue

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Recruiting

Start Date: October 29, 2010

Completed Date:

Phase:

Type: Observational

Design:

Primary Outcome: 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.

Secondary Outcome: White blood cell gene expression

Study sponsors, principal investigator, and references

Principal Investigator: Leorey N Saligan, C.R.N.P.

Lead Sponsor: National Institute of Nursing Research (NINR)

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01231932

Bower JE, Ganz PA, Aziz N, Fahey JL. Fatigue and proinflammatory cytokine activity in breast cancer survivors. Psychosom Med. 2002 Jul-Aug;64(4):604-11.

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