![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052221 |
RATIONALE: Epoetin alfa may help improve energy levels and quality of life in patients who have advanced solid tumors.
PURPOSE: Randomized clinical trial to study the effectiveness of epoetin alfa in treating fatigue in patients who are not receiving chemotherapy for advanced solid tumors.
Condition | Intervention |
---|---|
Fatigue Unspecified Adult Solid Tumor, Protocol Specific |
Drug: epoetin alfa |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | A Placebo Controlled Trial Of Short-Term, High-Dose Epoeitin Alfa In Advanced Cancer Outpatients With Mild Fatigue |
Study Start Date: | May 2003 |
Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2-3), and hemoglobin prior to study (10 mg/dL or less vs greater than10 mg/dL). Patients are randomized to one of two treatment arms.
In both arms, quality of life and fatigue are assessed at baseline and at 3 and 6 weeks. If patients receive an additional 6 weeks of therapy, quality of life and fatigue are also assessed at 9 and 12 weeks.
PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least somewhat bothered by fatigue based on self-report
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Colorado | |
CCOP - Colorado Cancer Research Program, Incorporated | |
Denver, Colorado, United States, 80224 | |
United States, Illinois | |
MBCCOP - University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612-7323 | |
United States, Kansas | |
CCOP - Wichita | |
Wichita, Kansas, United States, 67214-3882 | |
United States, Michigan | |
CCOP - Kalamazoo | |
Kalamazoo, Michigan, United States, 49007-3731 | |
United States, Missouri | |
CCOP - Cancer Research for the Ozarks | |
Springfield, Missouri, United States, 65807 | |
CCOP - Kansas City | |
Kansas City, Missouri, United States, 64131 | |
United States, Ohio | |
CCOP - Columbus | |
Columbus, Ohio, United States, 43206 | |
CCOP - Dayton | |
Dayton, Ohio, United States, 45429 | |
United States, South Carolina | |
CCOP - Greenville | |
Greenville, South Carolina, United States, 29615 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
United States, Wisconsin | |
CCOP - Marshfield Clinic Research Foundation | |
Marshfield, Wisconsin, United States, 54449 |
Study Chair: | Michael J. Fisch, MD, MPH, FACP | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000069409, MDA-DM-02331, MDA-DM-0038, NCI-P02-0225 |
Study First Received: | January 24, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00052221 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific fatigue |
Epoetin Alfa Signs and Symptoms Fatigue |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |