Investigating Molecular-Genetic Correlates of Fatigue Experienced by Cancer Patients Receiving Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Other Indications |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 9/13/2018 |
| Start Date: | October 29, 2010 |
| Contact: | Leorey N Saligan, C.R.N.P. |
| Email: | saliganl@mail.nih.gov |
| Phone: | (301) 451-1685 |
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.
- 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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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