Cancer Clinical Trial
Official title:
Pilot Web-based Study of Functional Status, Symptom Palliation and Quality of Life Benefits Associated With Darbepoetin Alfa (Aranesp®) Administration in Anemic Patients With Cancer.
NCT number | NCT00153868 |
Other study ID # | D-0341 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2003 |
Est. completion date | August 17, 2007 |
Verified date | September 2021 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | August 17, 2007 |
Est. primary completion date | August 17, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Confirmation of non-myeloid cancer (myeloproliferative disorders will be excluded). - Hemoglobin concentration = 11.0 g/dL. - Age = 18 years. - Karnofsky performance status = 60%. - Anemia predominantly due to cancer or chemotherapy. - Serum creatinine concentration = 2.0 mg/dL. - Total serum bilirubin = 1.5 times the upper limit of normal. - Nutritional status adequate to provide vitamin B12 and folate within the normal limits. - Capacity to complete the web-based functional status, symptom and quality of life assessments. - Ability to give informed consent. Exclusion Criteria: - Untreated symptomatic primary or metastatic cancer involving the central nervous system. - History of clinically significant iron deficiency. - Greater than two red blood cell transfusions within 2 weeks of registration or any red blood cell transfusion within 7 days of registration. - Received epoetin alfa or darbepoetin alfa therapy within 3 weeks prior to randomization. - History of a seizure disorder. - Unstable angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%) or uncontrolled cardiac arrhythmias. - Uncontrolled hypertension defined as a diastolic blood pressure > 100 mmHg. - Clinical evidence of active infection or inflammatory diseases such as rheumatoid arthritis. Subjects with active rheumatoid arthritis are excluded. - Known positive test for human immunodeficiency virus infection. - Known primary hematological disorder which could cause anemia such as sickle cell anemia. - Pregnant or breast-feeding. - Not using adequate contraception if of childbearing potential. - Known hypersensitivity to any recombinant mammalian-derived product. |
Country | Name | City | State |
---|---|---|---|
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Amgen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A secure web-based assessment of cancer-related symptoms (LCSS), functional status (SF-36), and quality of life (FACT-An and PFS) will be obtained every 2 weeks (weeks 3, 5, 7, 9, 11, and 13). | every 2 weeks (weeks 3, 5, 7, 9, 11, and 13) | ||
Secondary | A blood sample will be obtained to evaluate hemoglobin concentrations every 2 weeks (weeks 3, 5, 7, 9, 11, and 13). | every 2 weeks (weeks 3, 5, 7, 9, 11, and 13) | ||
Secondary | A blood sample will be obtained to evaluate plasma cytokines every 4 weeks (weeks 5, 9, and 13). | every 4 weeks (weeks 5, 9, and 13) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|
||
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|