AnemiaPhase 4NCT00153868
A Web-based Study of Quality of Life Benefits Associated Aranesp in Anemic Patients With Cancer
A Phase 4 study testing darbepoetin alfa in people with Anemia and Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to 17 Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
About this study
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.
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.
Read the detailed description
Anemia associated with lung cancer and chemotherapy is an important factor effecting patient symptoms, functional status, and overall quality of life (Groopman and Itri 1999; Langer, Choy et al. 2002). Darbepoetin alfa (Aranesp®) has demonstrated a significant effect upon ameliorating chemotherapy-induced anemia in lung cancer (Vansteenkiste, Pirker et al. 2002; Vansteenkiste, Poulsen et al. 2002). This trial is designed to evaluate the association between the treatment of anemia with darbepoetin alfa and direct electronic capture of clinical benefits in cancer-related symptoms, functional status and overall quality of life. This trial uses a secure web-based design to capture the patient-associated symptoms, functional status and quality of life. This novel secure web-based system was selected to improve the efficiency and quality of clinical data capture. If our hypothesis is correct, treatment with darbepoetin alfa will be associated with improved palliation of cancer-related symptoms, improved functional status, and result in overall benefits to the patient's health-related quality of life. The development of a web-based system to directly capture patient-related symptoms, functional status and quality of life will permit us in the future to conduct a national or international trial addressing the effects of darbepoetin alfa on these factors. If our hypothesis is incorrect, it may be that these parameters are not affected by the correction of anemia with darbepoetin alfa or the measures are not sensitive enough to detect these differences. A notable finding would be a clearly defined improvement in symptom palliation, functional status, and quality of life associated with darbepoetin alfa therapy.
- Being tested
- darbepoetin alfa
- Keywords
- Anemia, Cancer, Quality of life, Web-based, Aranesp, Darbepoetin alfa
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin alfaBiological
Also called aranesp
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Darbepoetin alfa 200 mcg with escalation to 300 mcg after 6 weeks (week 7 dose) for non-responders subcutaneously every 2 weeks for 12 weeks (weeks 1, 3, 5, 7, 9, and 11) Receives: Biological: darbepoetin alfa |
| 2 | Active comparator | darbepoetin alfa 300 mcg with escalation to 500 mcg after 6 weeks (week 7 dose) for non-responders subcutaneously every 3 weeks for 12 weeks (weeks 1, 4, 7, and 10) Receives: Biological: darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)
Secondary outcomes (2)
A blood sample will be obtained to evaluate hemoglobin concentrations every 2 weeks (weeks 3, 5, 7, 9, 11, and 13).
Measured: every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)
A blood sample will be obtained to evaluate plasma cytokines every 4 weeks (weeks 5, 9, and 13).
Measured: every 4 weeks (weeks 5, 9, and 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2003
- Primary completion17 Aug 2007
- Study completion17 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Konstantin Dragnev, Dartmouth-Hitchcock Medical Center
- Investigators
- James R Rigas, MD, Principal investigator, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153868
- Sponsor's protocol ID
- D-0341
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2005
- Last updated
- 23 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00153868
- Acronym / sponsor ID
- D-0341
- Keywords
- Anemia, Cancer, Quality of life, Web-based, Aranesp, Darbepoetin alfa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Oct 2003
- Primary completion
- 17 Aug 2007 (actual)
- Study completion
- 17 Aug 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anemia associated with lung cancer and chemotherapy is an important factor effecting patient symptoms, functional status, and overall quality of life (Groopman and Itri 1999; Langer, Choy et al. 2002). Darbepoetin alfa (Aranesp®) has demonstrated a significant effect upon ameliorating chemotherapy-induced anemia in lung cancer (Vansteenkiste, Pirker et al. 2002; Vansteenkiste, Poulsen et al. 2002). This trial is designed to evaluate the association between the treatment of anemia with darbepoetin alfa and direct electronic capture of clinical benefits in cancer-related symptoms, functional status and overall quality of life. This trial uses a secure web-based design to capture the patient-associated symptoms, functional status and quality of life. This novel secure web-based system was selected to improve the efficiency and quality of clinical data capture. If our hypothesis is correct, treatment with darbepoetin alfa will be associated with improved palliation of cancer-related symptoms, improved functional status, and result in overall benefits to the patient's health-related quality of life. The development of a web-based system to directly capture patient-related symptoms, functional status and quality of life will permit us in the future to conduct a national or international trial addressing the effects of darbepoetin alfa on these factors. If our hypothesis is incorrect, it may be that these parameters are not affected by the correction of anemia with darbepoetin alfa or the measures are not sensitive enough to detect these differences. A notable finding would be a clearly defined improvement in symptom palliation, functional status, and quality of life associated with darbepoetin alfa therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: darbepoetin alfaDarbepoetin alfa 200 mcg with escalation to 300 mcg after 6 weeks (week 7 dose) for non-responders subcutaneously every 2 weeks for 12 weeks (weeks 1, 3, 5, 7, 9, and 11) |
| 2 | Active comparator | Biological: darbepoetin alfadarbepoetin alfa 300 mcg with escalation to 500 mcg after 6 weeks (week 7 dose) for non-responders subcutaneously every 3 weeks for 12 weeks (weeks 1, 4, 7, and 10) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| darbepoetin alfaAlso: aranespThe 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. | Biological | 1, 2 |
Primary outcome
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).
Time frame: every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)
2 secondary outcomes
A blood sample will be obtained to evaluate hemoglobin concentrations every 2 weeks (weeks 3, 5, 7, 9, 11, and 13).
Time frame: every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)
A blood sample will be obtained to evaluate plasma cytokines every 4 weeks (weeks 5, 9, and 13).
Time frame: every 4 weeks (weeks 5, 9, and 13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Rigas, MD principal investigator
Norris Cotton Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing darbepoetin alfa in people with Anemia and Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: every 2 weeks (weeks 3, 5, 7, 9, 11, and 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.