Clinical trial NCT00337441: Treatment of Chronic Anemia With Epoetin Alfa in Elderly
Official title: Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anemia
Keywords: Chronic Anemia
Anemia
Chronic Diseases
Elderly
Epoetin alfa
Fatigue
Quality of life
Mobility
Lead sponsor: Research and Education Foundation of Michael Reese Hospital
Sponsor class: OTHER
Collaborators: name: Ortho Biotech Clinical Affairs, L.L.C.
name: Cook County Health
name: Mercy Hospital and Medical Center, Illinois
First posted: 2006-06-16
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or mobility among elderly.

Detailed description: Chronic Anemia is common among elderly. Given their somewhat non-specific nature, the clinical symptoms of anemia are often difficult to attribute directly to the anemia itself. However, it is known that anemic older adults are at an increased risk of mortality, disability, higher risk of falls, poorer quality of life, worsening cognitive function, increase hospitalization risk, and increased healthcare utilization than their non-anemic counterparts.

Yet so far, there have been no treatment studies to demonstrate the benefits of correction of chronic anemia.

Epoetin Alfa (Procrit) is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrow's production of red blood cells.

This study is to explore, can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue, quality of life or mobility among elderly.

Overall this is a 32 week treatment study.

In this study, participants with chronic anemia will receive either Epoetin alfa or placebo (saline injection) under the skin for 16 weeks. After 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks.

At the end of 32 weeks we will compare, if epoetin alfa corrected the anemia, how individuals felt in respect to their fatigue levels, quality of life and did mobility improve during the study.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or older Diagnosed with chronic anemia Hemoglobin level less than or equal to 11.5 g/dl Community dwelling Able to make monthly clinic visits

Exclusion Criteria:

* Currently on Epoetin alfa or similar preparations Having nutritional anemia Having active cancer or received recent treatment for cancer On treatment for Kidney disease Diagnosis of dementia Inability to ambulate

Primary outcomes:
measure: Hemoglobin
measure: Fatigue
measure: Quality of Life
Secondary outcomes:
measure: Quality of Life
measure: Mobility
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: Mercy Hospital and Medical Center
state: Illinois
Study officials:
affiliation: Research and Education Foundation of Michael Reese
name: Parag Agnihotri
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guralnik JM, Eisenstaedt RS, Ferrucci L, Klein HG, Woodman RC. Prevalence of anemia in persons 65 years and older in the United States: evidence for a high rate of unexplained anemia. Blood. 2004 Oct 15;104(8):2263-8. doi: 10.1182/blood-2004-05-1812. Epub 2004 Jul 6.
citation: Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
citation: Penninx BW, Pahor M, Cesari M, Corsi AM, Woodman RC, Bandinelli S, Guralnik JM, Ferrucci L. Anemia is associated with disability and decreased physical performance and muscle strength in the elderly. J Am Geriatr Soc. 2004 May;52(5):719-24. doi: 10.1111/j.1532-5415.2004.52208.x.
citation: Cella D, Zagari MJ, Vandoros C, Gagnon DD, Hurtz HJ, Nortier JW. Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. J Clin Oncol. 2003 Jan 15;21(2):366-73. doi: 10.1200/JCO.2003.02.136.