Optimal Transfusion in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)

Rigshospitalet

Status and phase: Terminated; Phase 2

Conditions: Anaemia; Cancer

Treatments: Other: Blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01116479

H-1-2009-109

Details and patient eligibility

About

This an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. Randomisation is performed 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.Primary end-point is quality of life

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Haemoglobin (<6.0 mmol/l)

Active Comparator group

Description:

Blood transfusion thresholds:Haemoglobin \< 6.0 mmol/l (9.9 g/dL)

Treatment:

Other: Blood transfusion

Haemoglobin (< normal range)

Experimental group

Description:

Blood transfusion threshold: Haemoglobin \< 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males

Treatment:

Other: Blood transfusion