Clinical trial NCT01444456: Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia
Official title: Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Breast Cancer
Cancer
Colorectal Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Solid Tumors
Bladder Cancer
Endometrial Cancer
Renal Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer
Keywords: Breast Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Colorectal Cancer
Aranesp
Chemotherapy induced anaemia
Chemotherapy
Bladder Cancer
Endometrial Cancer
Renal Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 1262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with either breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer who will receive darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) for the treatment of symptomatic chemotherapy-induced anaemia (CIA) in routine clinical practice.

Brief 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

Detailed 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.

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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL
timeFrame: Baseline to Week 9
measure: Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points
timeFrame: Baseline and Week 9
measure: Time to First Increase in Hemoglobin
timeFrame: From Baseline until Week 9
measure: Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time
timeFrame: From Baseline to Week 13
measure: Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time
timeFrame: From Baseline to Week 13
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: St Poelten
country: Austria
facility: Research Site
city: Vöcklabruck
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brasschaat
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Eupen
country: Belgium
facility: Research Site
city: Gilly
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Verviers
country: Belgium
facility: Research Site
city: Aix en Provence cedex 01
country: France
facility: Research Site
city: Aix en Provence
country: France
facility: Research Site
city: Aix en Provence
country: France
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Aubagne
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Besançon Cedex
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Boulogne sur Mer Cédex
country: France
facility: Research Site
city: Bourg en Bresse
country: France
facility: Research Site
city: Brive la Gaillarde
country: France
facility: Research Site
city: Carcassonne
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Colmar Cedex
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Draguignan Cedex
country: France
facility: Research Site
city: La Seyne Sur Mer
country: France
facility: Research Site
city: Le Mans Cedex 9
country: France
facility: Research Site
city: Longjumeau cedex 1
country: France
facility: Research Site
city: Marseille Cedex 03
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Mont de Marsan
country: France
facility: Research Site
city: Montauban cedex
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Orléans
country: France
facility: Research Site
city: Paris Cedex 20
country: France
facility: Research Site
city: Pontoise Cedex
country: France
facility: Research Site
city: Pringy Cedex
country: France
facility: Research Site
city: Périgueux cedex
country: France
facility: Research Site
city: Reims Cedex
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Saint Grégoire cedex
country: France
facility: Research Site
city: Saint Quentin
country: France
facility: Research Site
city: Soissons Cedex
country: France
facility: Research Site
city: Soyaux
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Vichy cedex
country: France
facility: Research Site
city: Villefranche Sur Saone Cedex
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bremerhaven
country: Germany
facility: Research Site
city: Gelsenkirchen
country: Germany
facility: Research Site
city: Goslar
country: Germany
facility: Research Site
city: Halle (Saale)
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Neunkirchen
country: Germany
facility: Research Site
city: Rotenburg (Wümme)
country: Germany
facility: Research Site
city: Soest
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Würselen
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Chania
country: Greece
facility: Research Site
city: Marousi
country: Greece
facility: Research Site
city: Papagou
country: Greece
facility: Research Site
city: Cefalù PA
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Amstelveen
country: Netherlands
facility: Research Site
city: Dordrecht
country: Netherlands
facility: Research Site
city: Enschede
country: Netherlands
facility: Research Site
city: Leiderdorp
country: Netherlands
facility: Research Site
city: Purmerend
country: Netherlands
facility: Research Site
city: Roosendaal
country: Netherlands
facility: Research Site
city: Vlissingen
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Konin
country: Poland
facility: Research Site
city: Koszalin
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lubin
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Walbrzych
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Alba Iulia
country: Romania
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Ramnicu Valcea
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Mouysset JL, Freier B, van den Bosch J, Levache CB, Bols A, Tessen HW, Belton L, Bohac GC, Terwey JH, Tonini G. Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study. Cancer Manag Res. 2016 Jan 21;8:1-10. doi: 10.2147/CMAR.S88110. eCollection 2016.