Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
18 Years
N/A
Both
Cancer, Anaemia
Trial Information
Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
Title:
Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients
Treated with Chemotherapy (HaemOPtimal)
Background:
Cancer patients treated with chemotherapy very often become anaemic, which have profound
negative impact of their quality of life. Blood transfusions can ameliorate symptoms caused
by anaemia. Data are lagging with regard to what threshold should be used when offering
blood transfusion.
Aim:
The primary aim is to determine which end-points reflect symptoms caused by anaemia in
cancer patients treated with chemotherapy. The secondary aims are to collect data to
estimate sample size in a future definitive study and to compare symptom relief using to
different transfusion thresholds.
End-points:
- Numeric Rating Scale measuring fatigue, dizziness, palpitations, headache, and dyspnea.
- FACT-G,
- FACT-An (Total anemia scale) including a fatigue subscale
- Patient-assessed WHO performance status
Design:
Open two-arm interventional randomised feasibility study
Intervention:
- Blood transfusion.
- Randomisation between two transfusion thresholds:
Haemoglobin < 6.0 mmol/l (9.9 g/dL) versus Haemoglobin < 7.1 mmol/l (11.7 g/dL) for female
and 8.1 mmol/l (13.4 g/dL) for males.
Population:
Cancer patients treated with chemotherapy
Inclusion criteria:
- Documented cancer
- Planned treatment with chemotherapy
- Age 18 years or older
- Informed consent
Exclusion criteria:
- Heart failure (NYHA 3 and 4)
- Prior serious complications to blood transfusion
- Medical conditions that require special considerations for blood transfusion
- Treatment with erythropoiesis-stimulating agents.
Number of patients:
Transfusion of at least 30 patients in each intervention arm. An estimated number of 90
patients will be randomised in each arm (180 in total) as a third of included patients are
expected to require transfusion.
Inclusion Criteria:
- Documented cancer
- Planned treatment with chemotherapy
- Age older than 18 years
- Informed consent
Exclusion Criteria:
- Heart failure (NYHA 3 and 4)
- Prior serious complications to blood transfusion
- Medical conditions that require special considerations for blood transfusion
- Treatment with erythropoiesis-stimulating agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status
Outcome Description:
Patient assessed FACT-G (Functional Assessment of Therapy in General), FACT-An (Functional Assessment of Therapy in Anaemia), Numeric Rating Scale on symptoms of anaemia (fatigue, dizziness, dyspnea, palpitations, headache) and performance status before each cycle of chemotherapy, before transfusion and daily in seven days after transfusion
Outcome Time Frame:
Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion
Safety Issue:
No
Principal Investigator
Morten Sorensen, MD, Phd
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept. of Oncology, Righospitalet, Denmark
Authority:
Denmark: Ethics Committee
Study ID:
H-1-2009-109
NCT ID:
NCT01116479
Start Date:
March 2010
Completion Date:
September 2012
Related Keywords:
- Cancer
- Anaemia
- Anaemia, transfusion, cancer, chemotherapy, Quality of life
- Anemia
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