- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01231932
Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors
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 completed cancer treatment.
Eligibility:
- Individuals at least 18 years of age.
- Receiving cancer treatment, OR 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.
Study Overview
Status
Conditions
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 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, radiation therapy and chemotherapy).
The primary objective of the study is to describe the changes in the self-reported fatigue experienced by cancer patients over time. The secondary objectives of this study are to (1) investigate the associations between inflammatory, neurometabolic, stress, and mitochondrial markers with fatigue intensification over time during the course of treatments, (2) determine changes in gene expression from peripheral blood samples over time during the course of treatments, (3) relate changes in the levels of these biological markers (i.e., inflammatory/metabolic/stress profiles and gene expression) to patient reported outcomes (PROs) of self-reported fatigue, sleep disturbance, depression, and health-related quality of life (HRQOL) scores, (4) measure cognitive functioning, skeletal muscle strength, physical activity levels and energy expenditure of patients and relate these findings with changes in PRO scores, the inflammatory/metabolic/stress profiles and gene expression, and (5) investigate the psychometric property of the Saligan-Walitt Integrated Fatigue Tool (SWIFT).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexander Ross, R.N.
- Phone Number: (301) 841-5068
- Email: alexander.ross2@nih.gov
Study Contact Backup
- Name: Leorey N Saligan, C.R.N.P.
- Phone Number: (301) 451-1685
- Email: saliganl@mail.nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Phone Number: TTY dial 711 800-411-1222
- Email: ccopr@nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Cancer survivors
Individuals recently completed primary treatment for cancer
|
Individuals receiving cancer treatment
|
Individuals with cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported fatigue
Time Frame: Up to 3 times throughout study
|
Self-reported fatigue
|
Up to 3 times throughout study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The inflammatory/metabolic/stress profile; gene expression changes; self-reported fatigue; sleep disturbance; depression; HRQOL scores; cognitive function; skeletal muscle strength; physical activity levels and energy expenditure; SWIFT scores.
Time Frame: Up to 3 times throughout study
|
The inflammatory/metabolic/stress profile; gene expression changes; self-reported fatigue; sleep disturbance; depression; HRQOL scores; cognitive function; skeletal muscle strength; physical activity levels and energy expenditure; SWIFT scores.
|
Up to 3 times throughout study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Leorey N Saligan, C.R.N.P., National Institute of Nursing Research (NINR)
Publications and helpful links
General Publications
- Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]. Neurol Neurochir Pol. 2007 Jul-Aug;41(4):340-9. Polish.
- 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. doi: 10.1097/00006842-200207000-00010.
- 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. doi: 10.1016/j.jpainsymman.2007.07.007. Epub 2008 Mar 20.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110014
- 11-NR-0014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States