A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 43
• Participant gender: Both

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Amgen
• Treatments: Darbepoetin alfa
• Last Updated: 2016-06-27

Criteria

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.