NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors

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;
Cytokines;
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 is a common side effect of cancer and its treatment. Up to 96% of patients with cancer have fatigue. The cause of fatigue in people with cancer or those receiving treatment is poorly understood, making fatigue hard to treat. More research is necessary to understand why cancer patients experience fatigue. Previous research has shown that fatigue may be caused by a number of factors, including problems with the immune system response of the body while undergoing cancer treatment. The researchers of this study are trying to understand how the immune system and other chemicals of the body change while a person receives cancer treatment and how these changes play a role in causing fatigue. The researchers are also interested in how a person s quality of life is affected by fatigue.

Objectives:

- To study fatigue in individuals who have cancer, are receiving cancer treatment, or have recently completed cancer treatment.

Eligibility:

- Individuals at least 18 years of age.

- Receiving cancer treatment, OR recently completed primary treatment for cancer (e.g., cancer survivors), OR on active surveillance for localized cancer.

Design:

- This study involves an initial screening visit and up to three outpatient visits.

- Participants will be screened with a medical history review (can be done virtually) and blood tests. A physical exam might also occur.

- Participants undergoing cancer treatment that has a clear completion date, will have the following visits:

--Before the start of treatment.

--At the end of treatment.

--At least 3 months after treatment ends.

- Participants not receiving treatment, are cancer survivors, or undergoing cancer treatment that does not have a clear completion date, will have up to 3 visits:

--Before the start of treatment or whenever you begin the study.

--At least 3 months after your first visit.

--At least 3 months after your second visit.

- At each study visit, participants will complete the following tasks (some of the tasks can be done from home or virtually):

--Questionnaires about physical activity, fatigue, depression, and quality of life (can be done at home or virtually).

--Have blood drawn.

--Physical activity device and journals to study how fatigue affects physical activity.

--Optional tests:

---Computer games testing your memory, attention, and ability to follow directions.

---Hand grip strength test to evaluate physical strength.

- Treatment will not be provided under this study.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

To be included, patients must meet all of the following criteria:

- Medical documentation confirming diagnosis of:

--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); OR Recently completed primary treatment for cancer (e.g., cancer survivors) OR on active surveillance for localized cancer;

-Able to provide written informed consent;

-Women and men greater than or equal to 18 years of age;

-Fluent in one of the existing language translations for Fatigue Scale;

-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;

--Chronic inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematosus).

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

-NINR employees or subordinates, relatives, and/or co-workers of NINR employees/staff or study investigators.

-Self-report of color-blindness verified by taking the Ishihara card test with scores >14 (10 minutes) will be an exclusion from the Stroop Test. This card test will be administered only if the patient reports being color blind.

-Severe essential hand tremor or severe hand pain (e.g., severe arthritis or severe carpel tunnel) will be an exclusion from the computerized tests and the skeletal muscle strength test.

-Ongoing medical condition that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study or safety of the participant.


--Back to Top--

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.

--Back to Top--

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

Angela Wang, R.N.
National Institute of Nursing Research (NINR)
National Institutes of Health
Building 60
Room 259
60 Cloister Court
Bethesda, Maryland 20892
(301) 841-5085
tzu-fang.wang@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

--Back to Top--