Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

Amgen

Status: Completed

Conditions: Anemia; Breast Cancer; Esophageal Cancer; Lung Cancer; Cancer; Solid Tumors; Ovarian Cancer; Endometrial Cancer; Bladder Cancer; Gastric Cancer; Renal Cancer; Prostate Cancer; Pancreatic Cancer; Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01444456

20101123

Details and patient eligibility

About

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia.

Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

Full description

Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those countries in which local regulations did not permit observational study participation by patients receiving a specific agent in a drug class.

Enrollment: 1,262 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer
• Expected to receive at least 8 additional weeks of a given regimen of myelosuppressive chemotherapy after enrolment
• Starting treatment with either darbepoetin alfa (in Cohort 1 countries) or any ESA (in Cohort 2 countries) as per European Summary of Product Characteristics (SPC) for symptomatic anaemia.

Exclusion criteria

• Received any ESA treatment or Red Blood Cell (RBC) transfusion within 28 days prior to enrolment
• Known primary benign or malignant haematologic disorder which can cause anaemia
• Known hypersensitivity to ESAs

Trial design

1,262 participants in 2 patient groups

Cohort 1: Darbepoetin alfa

Description:

Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.

Cohort 2: Any ESA

Description:

Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.