MedTrace Logo

A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer

NCT00153868 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-09-23

No results posted yet for this study

Summary

This is a web-based pilot study to evaluate the association between the treatment of anemia with darbepoetin alfa (aranesp) and the clinical benefits in symptom palliation, improved functional status and quality of life in patients with cancer. The feasibility of web-based assessments and data capture will be evaluated.

Conditions

Interventions

BIOLOGICAL

darbepoetin alfa

The allocation to the treatment arms will be dependent on the schedule of chemotherapy (i.e. weekly, every 2 week, or every 4 week chemotherapy schedules will receive a starting dose of 200 mcg darbepoetin alfa and every 3 week chemotherapy schedule will receive a starting dose of 300 mcg). Non-responders are defined as patients who experience \<1.0 g/dL increase in hemoglobin concentrations after 6 weeks. Darbepoetin alfa will be held for hemoglobin concentrations \>13.0 g/dL.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • James R Rigas, MD · Norris Cotton Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2007-08-17
Completion
2007-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00153868 on ClinicalTrials.gov