CancerNCT01231932
Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors
An observational study of Cancer and Fatigue, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial 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 poorly understood, making fatigue hard to treat. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer, Fatigue, Prostate Cancer
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2011to 16 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is actively enrolling patients from referrals obtained from NCI and from PRPL.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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).
- Conditions
- Cancer, Fatigue, Prostate Cancer, Breast Cancer, Cancer Survivor
- Keywords
- Fatigue, Cytokines, Cancer Therapy, Cancer Treatment, Gene Expression Patterns, Natural History, Cancer
- Medical subject headings
- Neoplasms, Fatigue, Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer survivors | Individuals recently completed primary treatment for cancer | |
| Individuals receiving cancer treatment | Individuals receiving cancer treatment | |
| Individuals with cancer | Individuals with cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported fatigue
Self-reported fatigue
Measured: Up to 3 times throughout study
Secondary outcomes (1)
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.
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.
Measured: Up to 3 times throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study start4 Feb 2011
- Primary completion1 Nov 2024
- Study completion16 Apr 2025
Why it stopped: Principal Investigator (PI) of this study is retiring.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leorey N Saligan, C.R.N.P., Principal investigator, National Institute of Nursing Research (NINR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231932
- Sponsor's protocol ID
- 110014
- Other IDs
- 11-NR-0014
- Status last verified
- Jun 2025
- First submitted
- 29 Oct 2010
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12140350Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]. Neurol Neurochir Pol. 2007 Jul-Aug;41(4):340-9. Polish.
PubMed 17874343Miaskowski 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.
PubMed 18358683
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors
- ClinicalTrials.gov ID
- NCT01231932
- Acronym / sponsor ID
- 110014
- Conditions
- Cancer, Fatigue, Prostate Cancer, Breast Cancer, Cancer Survivor
- Keywords
- Fatigue, Cytokines, Cancer Therapy, Cancer Treatment, Gene Expression Patterns, Natural History, Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator (PI) of this study is retiring.
- Enrolment
- 163 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 4 Feb 2011 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer survivors | – | –Individuals recently completed primary treatment for cancer |
| Individuals receiving cancer treatment | – | –Individuals receiving cancer treatment |
| Individuals with cancer | – | –Individuals with cancer |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is actively enrolling patients from referrals obtained from NCI and from PRPL.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reported fatigue
Time frame: Up to 3 times throughout study
Self-reported fatigue
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Principal Investigator (PI) of this study is retiring.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Background: PubMed 12140350Bower 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.
- Background: PubMed 17874343Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]. Neurol Neurochir Pol. 2007 Jul-Aug;41(4):340-9. Polish.
- Background: PubMed 18358683Miaskowski 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leorey N Saligan, C.R.N.P. principal investigator
National Institute of Nursing Research (NINR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Fatigue, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator (PI) of this study is retiring.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported fatigue (time frame: Up to 3 times throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231932, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.