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

NCT ID: NCT01444456

Last Updated: 2017-03-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Darbepoetin alfa

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

No interventions assigned to this group

Cohort 2: Any ESA

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Saint-Quentin, , France

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Soissons, , France

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Soyaux, , France

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Strasbourg, , France

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Vichy, , France

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Villefranche-sur-Saône, , France

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Villejuif, , France

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Augsburg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bremerhaven, , Germany

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Cologne, , Germany

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Gelsenkirchen, , Germany

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Goslar, , Germany

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Halle, , Germany

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Mannheim, , Germany

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Neunkirchen, , Germany

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Rotenburg (Wümme), , Germany

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Soest, , Germany

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Stralsund, , Germany

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Würselen, , Germany

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Athens, , Greece

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Athens, , Greece

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Chania, , Greece

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Marousi, , Greece

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Papagou, , Greece

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Cefalù PA, , Italy

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Napoli, , Italy

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Padua, , Italy

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Roma, , Italy

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Enschede, , Netherlands

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Flushing, , Netherlands

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Leiderdorp, , Netherlands

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Purmerend, , Netherlands

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Roosendaal, , Netherlands

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Zutphen, , Netherlands

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Bialystok, , Poland

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Gdansk, , Poland

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Konin, , Poland

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Koszalin, , Poland

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Krakow, , Poland

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Lubin, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Wałbrzych, , Poland

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Wroclaw, , Poland

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Torino, , Italy

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Amstelveen, , Netherlands

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Dordrecht, , Netherlands

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Graz, , Austria

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Innsbruck, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Vöcklabruck, , Austria

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Wels, , Austria

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Aalst, , Belgium

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Bonheiden, , Belgium

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Brasschaat, , Belgium

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Bruges, , Belgium

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Eupen, , Belgium

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Gilly, , Belgium

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Mechelen, , Belgium

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Namur, , Belgium

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Ostend, , Belgium

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Sint-Niklaas, , Belgium

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Verviers, , Belgium

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Aix-en-Provence, , France

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Aix-en-Provence, , France

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Amiens, , France

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Aubagne, , France

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Bayonne, , France

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Besançon, , France

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Bordeaux, , France

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Boulogne Sur Mer Cédex, , France

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Bourg-en-Bresse, , France

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Brive-la-Gaillarde, , France

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Carcassonne, , France

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Clermont-Ferrand, , France

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Clermont-Ferrand, , France

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Colmar, , France

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Dijon, , France

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Draguignan, , France

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La Seyne-sur-Mer, , France

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Le Mans, , France

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Longjumeau, , France

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Marseille, , France

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Marseille, , France

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Mont-de-Marsan, , France

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Montauban, , France

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Nancy, , France

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Orléans, , France

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Paris, , France

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Périgueux, , France

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Pontoise, , France

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Pringy, , France

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Reims, , France

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Reims, , France

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Reims, , France

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Rennes, , France

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Rouen, , France

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Saint-Grégoire, , France

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Wroclaw, , Poland

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Alba Iulia, , Romania

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Baia Mare, , Romania

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Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Oradea, , Romania

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Râmnicu Vâlcea, , Romania

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Târgu Mureş, , Romania

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Timișoara, , Romania

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Countries

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Austria Belgium France Germany Greece Italy Netherlands Poland Romania

References

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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.

Reference Type BACKGROUND
PMID: 26855598 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101123

Identifier Type: -

Identifier Source: org_study_id

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