Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00060398|
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 12, 2009
RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or without dexamethasone in treating anemia-related fatigue in patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying epoetin alfa and dexamethasone to see how well they work compared to epoetin alfa alone in treating anemia-related fatigue in patients with prostate cancer that is refractory to treatment with hormone therapy.
|Condition or disease||Intervention/treatment||Phase|
|Anemia Fatigue Prostate Cancer||Biological: epoetin alfa Drug: dexamethasone||Phase 3|
- Compare the effect of epoetin alfa with or without dexamethasone on the level of cancer-related fatigue measured by the FACIT fatigue subscale, in patients with hormone-refractory prostate cancer.
- Compare the effect of these regimens on increasing hemoglobin levels in these patients.
- Compare the effect of these regimens on palliation of other disease-related symptoms and on functional status and overall quality of life of these patients.
- Compare the survival rate of these regimens in these patients.
- Compare the toxicity profile of these regimens in these patients.
- Determine the incidence of adrenal suppression in these patients after receiving dexamethasone therapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive epoetin alfa subcutaneously once a week.
- Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day.
In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.
Quality of life and fatigue are assessed at baseline and then at 4, 8, and 12 weeks.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 282 patients (141 per treatment arm) will be accrued for this study within approximately 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||282 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Study Of Epoetin Alfa Vs Epoetin Alfa With Dexamethasone In Hormone Refractory Prostate Cancer Patients: Impact On Fatigue, Anemia, Functional Status And Quality Of Life|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||June 2006|
- Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale
- Anemia response at 3 months
- Functional level as measured by the Functional Assessment of Cancer Therapy-General Scale and Brief Fatigue Inventory functional interference score monthly
- Symptom distress as measured by the Memorial Symptom Assessment Scale-Short Form and the number of symptoms monthly
- Quality of life as measured by the Functional Assessment of Cancer Therapy-General Scale monthly
- Survival at 6 months
- Adrenal suppression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060398
|Study Chair:||Shirley S. Hwang, RN, MS||Veterans Affairs Medical Center - East Orange|