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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center Amgen |
Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00153868 |
This is a web-based pilot study to evaluate the association between the treatment of anemia with darbepoetin alfa (aranesp) and the clinical benefits in symptom palliation, improved functional status and quality of life in patients with cancer. The feasibility of web-based assessments and data capture will be evaluated.
Condition | Intervention |
Anemia Cancer |
Drug: darbepoetin alfa |
MedlinePlus related topics: | Anemia Cancer |
ChemIDplus related topics: | Darbepoetin alfa |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Pilot Web-Based Study of Functional Status, Symptom Palliation and Quality of Life Benefits Associated With Darbepoetin Alfa (Aranesp®) Administration in Anemic Patients With Cancer. |
Estimated Enrollment: | 103 |
Study Start Date: | October 2003 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Darbepoetin alfa 200 mcg with escalation to 300 mcg after 6 weeks (week 7 dose) for non-responders subcutaneously every 2 weeks for 12 weeks (weeks 1, 3, 5, 7, 9, and 11)
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Drug: darbepoetin alfa
The allocation to the treatment arms will be dependent on the schedule of chemotherapy (i.e. weekly, every 2 week, or every 4 week chemotherapy schedules will receive a starting dose of 200 mcg darbepoetin alfa and every 3 week chemotherapy schedule will receive a starting dose of 300 mcg). Non-responders are defined as patients who experience <1.0 g/dL increase in hemoglobin concentrations after 6 weeks. Darbepoetin alfa will be held for hemoglobin concentrations >13.0 g/dL.
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2: Active Comparator
darbepoetin alfa 300 mcg with escalation to 500 mcg after 6 weeks (week 7 dose) for non-responders subcutaneously every 3 weeks for 12 weeks (weeks 1, 4, 7, and 10)
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Drug: darbepoetin alfa
The allocation to the treatment arms will be dependent on the schedule of chemotherapy (i.e. weekly, every 2 week, or every 4 week chemotherapy schedules will receive a starting dose of 200 mcg darbepoetin alfa and every 3 week chemotherapy schedule will receive a starting dose of 300 mcg). Non-responders are defined as patients who experience <1.0 g/dL increase in hemoglobin concentrations after 6 weeks. Darbepoetin alfa will be held for hemoglobin concentrations >13.0 g/dL.
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Anemia associated with lung cancer and chemotherapy is an important factor effecting patient symptoms, functional status, and overall quality of life (Groopman and Itri 1999; Langer, Choy et al. 2002). Darbepoetin alfa (Aranesp®) has demonstrated a significant effect upon ameliorating chemotherapy-induced anemia in lung cancer (Vansteenkiste, Pirker et al. 2002; Vansteenkiste, Poulsen et al. 2002). This trial is designed to evaluate the association between the treatment of anemia with darbepoetin alfa and direct electronic capture of clinical benefits in cancer-related symptoms, functional status and overall quality of life. This trial uses a secure web-based design to capture the patient-associated symptoms, functional status and quality of life. This novel secure web-based system was selected to improve the efficiency and quality of clinical data capture. If our hypothesis is correct, treatment with darbepoetin alfa will be associated with improved palliation of cancer-related symptoms, improved functional status, and result in overall benefits to the patient's health-related quality of life. The development of a web-based system to directly capture patient-related symptoms, functional status and quality of life will permit us in the future to conduct a national or international trial addressing the effects of darbepoetin alfa on these factors. If our hypothesis is incorrect, it may be that these parameters are not affected by the correction of anemia with darbepoetin alfa or the measures are not sensitive enough to detect these differences. A notable finding would be a clearly defined improvement in symptom palliation, functional status, and quality of life associated with darbepoetin alfa therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Hampshire | |||||
Norris Cotton Cancer Center | |||||
Lebanon, New Hampshire, United States, 03756 |
Dartmouth-Hitchcock Medical Center |
Amgen |
Principal Investigator: | James R Rigas, MD | Norris Cotton Cancer Center |
Responsible Party: | Dartmouth-Hitchcock Medical Center ( James R. Rigas ) |
Study ID Numbers: | D-0341 |
First Received: | September 8, 2005 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00153868 |
Health Authority: | United States: Institutional Review Board |
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