Status:
TERMINATED
Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Cancer
Fatigue
Eligibility:
All Genders
18-120 years
Brief Summary
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 ...
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 pre...
Eligibility Criteria
Inclusion
- 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 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;
- 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 history of unstable major depression, bipolar disease, psychosis, or alcohol/drug dependence/abuse; requiring hospitalization/institutionalization;
- 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.
Exclusion
Key Trial Info
Start Date :
February 4 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 16 2025
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01231932
Start Date
February 4 2011
End Date
April 16 2025
Last Update
June 19 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892