Exercise to Relieve Cancer-Related Insomnia and Fatigue - Full Text View

Sponsors and Collaborators:	University of Arkansas National Institutes of Health (NIH) Ortho Biotech Clinical Affairs, L.L.C.
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00577096

Purpose

Our hypotheses are that HBIEP will improve cancer-related insomnia and decrease cancer-related fatigue. The study is a randomized trial with repeated measures of 200 patients receiving high dose chemotherapy as treatment for multiple myeloma. Data analysis includes descriptive statistics, analysis of variance, and path analysis.

Condition	Intervention
Multiple Myeloma	Drug: Procrit

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Exercise and Physical Fitness Multiple Myeloma

Drug Information available for: Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Exercise to Relieve Cancer-Related Insomnia and Fatigue

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Primary outcome measure of the Home-Based Individualized Exercise Program (HBIEP) and polysomnography to explore the effects of the HBIEP on sleep stages in a sub-sample [ Time Frame: varies with each participant, participation is Test 1:Baseline-before starting chemotherapy, Test 2:Before CAD and stem cell collection, Test 3: After stem cell collection and before DCEP ] [ Designated as safety issue: Yes ]

Enrollment:	187
Study Start Date:	May 2005
Study Completion Date:	September 2007

Arms	Assigned Interventions
exercise: Active Comparator Approximately 1/2 of the study participants were computer randomized to an individualized exercise program	Drug: Procrit Procrit was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. Varied with each participant, depended on hemoglobin level.
usual care Study participants were asked to remain as active as possible but not prescribed an individualized exercise program	Drug: Procrit Procrit was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. Varied with each participant, depended on hemoglobin level.

Detailed Description:

Specific Aims are to:

Compare the effects of the Home Based Individualized Exercise Program (HBIEP) with the effects of a usual care/control condition on nighttime sleep.

We hypothesize that patients who receive the HBIEP will show significantly greater increases in nighttime sleep than patients who receive the usual care/control condition.
Compare the effects of the HBIEP with the effects of a usual care/control condition on fatigue.

We hypothesize that patients who receive the HBIEP will show significantly less fatigue than patients who receive the usual care/control condition.
Explore the effects of the HBIEP or a usual care/control condition on Stages 2, 3 and 4 non-rapid eye movement (NREM) sleep and rapid eye movement (REM) sleep.

We hypothesize that patients who receive the HBIEP will have significantly greater increases in the percentage of Stages 2, 3 and 4 NREM and REM sleep than patients who receive the usual care/control condition.
Examine the relationships among HBIEP, aerobic capacity, muscle strength, daytime sleep, physical activity, nighttime sleep and fatigue.

We hypothesize that the (a) exercise program will be associated with increased aerobic capacity and muscle strength, (b) increased aerobic capacity and muscle strength will be associated with increased nighttime sleep and increased physical activity and decreased daytime sleep, and (c) increased nighttime sleep will be associated with decreased fatigue. The long-term objective is to improve the quality of life for patients receiving cancer treatment. As their physical activity and functional status improve, patients can continue to manage their activities of daily living and may be more likely to continue with cancer treatment.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Those who were not at high risk for impending pathologic fracture or cord compression, as determined by magnetic resonance imaging and other radiology reports and physician assessments,and enrolled in Total Therapy treatment protocols were invited to participate in the study.

Exclusion Criteria:

Patients were excluded if they showed any of the following attributes/conditions:

Inability to understand the intent of the study
Current diagnosis with a major psychiatric illness
Presence of microcytic or macrocytic anemia
Uncontrolled hypertension
Red cell transfusions within 2 weeks; and
Recombinant epoetin alfa within 8 weeks of study enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577096

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

National Institutes of Health (NIH)

Ortho Biotech Clinical Affairs, L.L.C.

Investigators

Study Director:

Sharon K Coon

University of Oklahoma

More Information

Responsible Party:	University of Arkansas for Medical Sciences ( Elizabeth Ann Coleman, PhD, RNP, AOCN )
Study ID Numbers:	IRB # 29287, 1 R01 NR008937-01A1
Study First Received:	December 17, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00577096
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

multiple myeloma
polysomnography
quality of life
exercise

Study placed in the following topic categories:

Epoetin Alfa
Fatigue
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Quality of Life

Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009