Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia (DOSE)

Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

The purpose of this study is to describe patient characteristics, treatment patterns, and clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating therapy (EST).

Study Overview

• Status: Completed
• Conditions: Cancer; Anemia
• Intervention / Treatment: Other: Patients with chemotherapy induced anemia

Detailed Description

The Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (DOSE) is a prospective, observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with EST; eg, epoetin alfa or darbepoetin alfa. The planned duration of the DOSE Registry is three years. Based on initial results, the registry sponsor may elect to extend the duration of the registry.This study does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on baseline patient characteristics, treatment patterns, and clinical outcomes. Baseline determinations will include patient demographics, tumor and treatment type, hematologic parameters, and patient reported outcomes. Data will be collected over the 16-week study period with regard to EST treatment, hematologic outcomes and patient reported outcomes.

• Study Type: Observational
• Enrollment (Actual): 2130

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are being treated with an erythropoiesis-stimulating therapy for chemotherapy induced anemia.

Description

Inclusion Criteria:

• Patients with cancer who are being treated with an erythropoiesis-stimulating therapy (EST) for anemia of cancer or cancer-related treatment
• Must be EST ''naive'' globally or must have been off treatment with an EST for at least 90 days
• Must speak and read english and be able to answer the type of simple questions presented in the patient questionnaires
• If the patient is identified for the study while an inpatient, they must be able to be followed for up to 16 weeks
• The patient must give consent to participate in the registry by signing the informed consent form

Exclusion Criteria:

• Patients currently participating in any other clinical study of EST (however, the patient may be undergoing treatment under an investigational cancer treatment protocol)
• Have or had been on dialysis for end stage renal disease in the past
• Has myelodysplasia or any myelodysplastic syndrome
• Patients are known to need stem cell transplant
• Patient who will self-administer the epoetin alfa or darbepoetin alfa

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chemotherapy induced anemia	Other: Patients with chemotherapy induced anemia; Physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the database. Patients will have to fill the questionaire at the time of enrollment and baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To document patient characteristics and patterns of clinical management	The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the relationships between patient characteristics, treatment patterns and outcomes	Up to 3 years
To measure economic impacts, and quality of life	Up to 3 years

Collaborators and Investigators

• Sponsor: Ortho Biotech Products, L.P.

Publications and helpful links

General Publications

• Larholt K, Pashos CL, Wang Q, Bookhart B, McKenzie RS, Piech CT. Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) : a registry for characterizing anaemia management and outcomes in oncology patients. Clin Drug Investig. 2008;28(3):159-67. doi: 10.2165/00044011-200828030-00003.

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): June 30, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Cancer; Anemia; Darbepoetin alfa; Registry; Epoetin alfa
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: CR004561; ABT-OP-03-02 (Other Identifier: Ortho Biotech Products, L.P.)