AnemiaPhase 2NCT00559195
Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors
A Phase 2 study testing epoetin beta and quality-of-life assessment in people with Anemia and Fatigue, run by Centre Hospital Regional Universitaire de Limoges at 1 site in France.
Trial summary
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care. PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- epoetin beta and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2005to May 2011
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant solid tumor
- No hematologic malignancy
- Hemoglobin < 10.5 g/dL (anemic)
- Receiving palliative care only
PATIENT CHARACTERISTICS:
- Life expectancy > 6 months
- Negative pregnancy test
- Fertile patients must use effective contraception
- No chronic anemia requiring treatment (e.g., thalassemia or sickle cell disease)
- No uncontrolled hypertension
- No allergy to any drugs or components used in the study
- Not a prisoner or under guardianship or trusteeship
- No mental disability that impairs a clear understanding of the study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 months since prior specific anticancer therapy (e.g., chemotherapy, hormonal therapy, targeted therapy, or immunotherapy)
- More than 1 month since prior and no concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.
PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.
Secondary
- Evaluate the impact of epoetin beta on hemoglobin level (increase > 2 g/dL).
OUTLINE: Patients receive epoetin beta subcutaneously once a week for up to 3 months.
Fatigue, quality of life, and hemoglobin and reticulocyte levels are assessed every 4 weeks.
- Being tested
- epoetin beta, quality-of-life assessment
- Keywords
- unspecified adult solid tumor, protocol specific, anemia, fatigue
- Medical subject headings
- Anemia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin betaBiological
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Quality of life
Secondary outcomes (1)
Hemoglobin level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startNov 2005
- Primary completionMay 2011
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.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospital Regional Universitaire de Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Luc Labourey, Study chair, Centre Hospital Regional Universitaire de Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559195
- Sponsor's protocol ID
- CDR0000574173
- Other IDs
- CHUL-NEOPALIA, RECF0359
- Status last verified
- May 2011
- First submitted
- 15 Nov 2007
- Last updated
- 16 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor
- ClinicalTrials.gov ID
- NCT00559195
- Acronym / sponsor ID
- CDR0000574173
- Keywords
- unspecified adult solid tumor, protocol specific, anemia, fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospital Regional Universitaire de LimogesUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- May 2011 (actual)
- First posted
- 16 Nov 2007 (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.
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.
PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.
Detailed description
OBJECTIVES:
Primary
- Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.
Secondary
- Evaluate the impact of epoetin beta on hemoglobin level (increase > 2 g/dL).
OUTLINE: Patients receive epoetin beta subcutaneously once a week for up to 3 months.
Fatigue, quality of life, and hemoglobin and reticulocyte levels are assessed every 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| epoetin beta | Biological | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Fatigue
Quality of life
1 secondary outcome
Hemoglobin level
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 16 May 2011.
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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.
Jean-Luc Labourey study chair
Centre Hospital Regional Universitaire de Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epoetin beta and quality-of-life assessment in people with Anemia and Fatigue, run by Centre Hospital Regional Universitaire de Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 May 2011. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Fatigue. The study lists 2 primary outcomes in all. 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 16 May 2011.