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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)

Conditions
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Cancer, Anaemia

Intervention / Treatment
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* Other: Blood transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haemoglobin (<6.0 mmol/l)<br>Blood transfusion thresholds:Haemoglobin < 6.0 mmol/l (9.9 g/dL) | Other: Blood transfusion<br>* Blood transfusion with packed erythrocytes<br>|
| Experimental: Haemoglobin (< normal range)<br>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 | Other: Blood transfusion<br>* Blood transfusion with packed erythrocytes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and transfusion complications | Frequency of complications to blood transfusion (need for termination of transfusion due to complications, chills, fever, hives, drop in blood pressure, dyspnea, other) | during or after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaemia, transfusion, cancer, chemotherapy, Quality of life