Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia
This study is currently recruiting participants.
Verified April 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01444456
First received: September 29, 2011
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
This is a multicenter, international, prospective, observational study of subjects 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 ESA to treat symptomatic anaemia.
Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those subjects receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of >=1 g/dL
| Condition |
|---|
|
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 Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA) |
Resource links provided by NLM:
MedlinePlus related topics:
Anemia
Benign Tumors
Bladder Cancer
Breast Cancer
Cancer
Colorectal Cancer
Esophageal Cancer
Esophagus Disorders
Fatigue
Kidney Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Stomach Cancer
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Proportion of subjects receiving darbepoetin alfa with improvement in Patient Perceived Fatigue (PPF) and increase in Hb >=1 g/dL [ Time Frame: From Baseline to Week 9 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects by tumour type with improvement in Patient Perceived Fatigue (PPF) and increase in Hb >=1 g/dL [ Time Frame: From Baseline to Week 9 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1300 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Patients taking Aranesp |
| Patients taking any ESA |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444456
Show 124 Study Locations
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Show 124 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01444456 History of Changes |
| Other Study ID Numbers: | 20101123 |
| Study First Received: | September 29, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Austria: Bundesamt für Sicherheit im Gesundheitswesen Austria: Central Ethics Committee Belgium: Ethisch committee Imelda ziekenhuis Bonheiden Germany: Central associations of the statutory health insurance funds Germany: Ethics Committee Germany: Federal Institute for Drugs and Medical Devices Germany: Federal Panel Doctors' Association Italy: Comitato Etico della Fondazione Istituto San Raffaele-G.Giglio di Cefalù Netherlands: METOPP (Medisch-Ethische Toetsing Onderzoek Patiënten en Proefpersonen) France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: French Data Protection Authority Romania: Ministry of Public Health |
Keywords provided by Amgen:
|
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 |
Additional relevant MeSH terms:
|
Anemia Urinary Bladder Neoplasms Breast Neoplasms Endometrial Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Colorectal Neoplasms Esophageal Diseases Esophageal Neoplasms Lung Neoplasms Stomach Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Prostatic Neoplasms Adenoma |
Hematologic Diseases Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Uterine Diseases Genital Diseases, Female Adenocarcinoma Carcinoma |
ClinicalTrials.gov processed this record on May 22, 2013