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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-NR-0014

Sponsoring Institute

National Institute of Nursing Research (NINR)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 100

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Fatigue;
Cancer;
Cancer Therapy;
Cancer Treatment;
Gene Expression Patterns

Recruitment Keyword(s)

Cancer;
Cancer Treatment;
Fatigue

Condition(s)

Cancer;
Fatigue

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Nursing Research

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.

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Eligibility

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.


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Citations:

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.

Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]. Neurol Neurochir Pol. 2007 Jul-Aug;41(4):340-9.

Miaskowski C, Paul SM, Cooper BA, Lee K, Dodd M, West C, Aouizerat BE, Swift PS, Wara W. Trajectories of fatigue in men with prostate cancer before, during, and after radiation therapy. J Pain Symptom Manage. 2008 Jun;35(6):632-43. Epub 2008 Mar 20.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leorey N. Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
BG 3 RM 5E14
3 CENTER DR
BETHESDA MD 20814
(301) 451-1685
saliganl@mail.nih.gov

Leorey N. Saligan, C.R.N.P.
National Institute of Nursing Research (NINR)
BG 3 RM 5E14
3 CENTER DR
BETHESDA MD 20814
(301) 451-1685
saliganl@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01231932

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