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

NCT01231932 | Terminated

• 2 other identifiers: 11001411-NR-0014
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cancer; Fatigue; Prostate Cancer; Breast Cancer; Cancer Survivor

Keywords

Fatigue; Cytokines; Cancer Therapy; Cancer Treatment; Gene Expression Patterns; Natural History; Cancer

Outcome Measures

Primary Outcomes (1)

• Self-reported fatigue

  Self-reported fatigue

  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.

  Up to 3 times throughout study

Study Arms (3)

Cancer survivors

Individuals recently completed primary treatment for cancer

Individuals receiving cancer treatment

Individuals receiving cancer treatment

Individuals with cancer

Individuals with cancer

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is actively enrolling patients from referrals obtained from NCI and from PRPL.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 12140350 BACKGROUND

• Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]. Neurol Neurochir Pol. 2007 Jul-Aug;41(4):340-9. Polish.

  PMID: 17874343 BACKGROUND

• 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.

  PMID: 18358683 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms; Fatigue; Prostatic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Leorey N Saligan, C.R.N.P.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 1, 2010
• Study Start: February 4, 2011
• Primary Completion: November 1, 2024
• Study Completion: April 16, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (1)