N/A
Completed N=1,262
Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia
Source: ClinicalTrials.gov NCT01444456 ↗Enrolled (actual)
1,262
Serious AEs
0.2%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL — 31.8 percentage of participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL |
31.8 | — |
| SECONDARY Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL |
38.8; 28.2; 16.7; 28.6; 31.0; 38.0 | — |
| SECONDARY Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points |
3.5 | — |
| SECONDARY Time to First Increase in Hemoglobin |
36.5 | — |
| SECONDARY Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time |
70.0 | — |
| SECONDARY Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time |
75.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01444456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.