CompletedNot Applicable

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

Austria1,262 participantsStarted 2011-10

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL

Timeframe: Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.

Trial details

NCT IDNCT01444456

SponsorAmgen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-08

Results submitted2014-07-24

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