Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients
Treated with Chemotherapy (HaemOPtimal)
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
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.
- Numeric Rating Scale measuring fatigue, dizziness, palpitations, headache, and dyspnea.
- FACT-An (Total anemia scale) including a fatigue subscale
- Patient-assessed WHO performance status
Open two-arm interventional randomised feasibility study
- 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.
Cancer patients treated with chemotherapy
- Documented cancer
- Planned treatment with chemotherapy
- Age 18 years or older
- Informed consent
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status
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
Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion
Morten Sorensen, MD, Phd
Dept. of Oncology, Righospitalet, Denmark
Denmark: Ethics Committee