Clinical trial NCT01116479: Optimal Transfusion in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
Official title: Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Anaemia
Keywords: Anaemia, transfusion, cancer, chemotherapy, Quality of life
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status
timeFrame: Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion
Secondary outcomes:
measure: Safety and transfusion complications
timeFrame: during or after transfusion
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Blood bank, Righospitalet
city: Copenhagen
country: Denmark
facility: Dept. of Oncology, Rigshospitalet
Study officials:
affiliation: Dept. of Oncology, Righospitalet, Denmark
name: Morten Sorensen, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.