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.
18 Years
N/A
Both
Anemia, Cancer
Trial Information
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.
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.
Inclusion Criteria:
- Confirmation of non-myeloid cancer (myeloproliferative disorders will be excluded).
- Hemoglobin concentration ≤ 11.0 g/dL.
- Age ≥ 18 years.
- Karnofsky performance status ≥ 60%.
- Anemia predominantly due to cancer or chemotherapy.
- Serum creatinine concentration ≤ 2.0 mg/dL.
- Total serum bilirubin ≤ 1.5 times the upper limit of normal.
- Nutritional status adequate to provide vitamin B12 and folate within the normal
limits.
- Capacity to complete the web-based functional status, symptom and quality of life
assessments.
- Ability to give informed consent.
Exclusion Criteria:
- Untreated symptomatic primary or metastatic cancer involving the central nervous
system.
- History of clinically significant iron deficiency.
- Greater than two red blood cell transfusions within 2 weeks of registration or any
red blood cell transfusion within 7 days of registration.
- Received epoetin alfa or darbepoetin alfa therapy within 3 weeks prior to
randomization.
- History of a seizure disorder.
- Unstable angina, congestive heart failure (New York Heart Association > class II or
known ejection fraction < 40%) or uncontrolled cardiac arrhythmias.
- Uncontrolled hypertension defined as a diastolic blood pressure > 100 mmHg.
- Clinical evidence of active infection or inflammatory diseases such as rheumatoid
arthritis. Subjects with active rheumatoid arthritis are excluded.
- Known positive test for human immunodeficiency virus infection.
- Known primary hematological disorder which could cause anemia such as sickle cell
anemia.
- Pregnant or breast-feeding.
- Not using adequate contraception if of childbearing potential.
- Known hypersensitivity to any recombinant mammalian-derived product.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
A secure web-based assessment of cancer-related symptoms (LCSS), functional status (SF-36), and quality of life (FACT-An and PFS) will be obtained every 2 weeks (weeks 3, 5, 7, 9, 11, and 13).
Outcome Time Frame:
every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)
Safety Issue:
No
Principal Investigator
James R Rigas, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
D-0341
NCT ID:
NCT00153868
Start Date:
October 2003
Completion Date:
July 2013
Related Keywords:
- Anemia
- Cancer
- Anemia
- Cancer
- Quality of life
- Web-based
- Aranesp
- Darbepoetin alfa
- Anemia
Name | Location |
|---|---|
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
