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

Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anaemia
• Cancer

• NCT number: NCT01116479
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Status: Terminated
• Phase: Phase 2
• Start date: March 2010
• Completion date: December 2013