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

Phase 2

Terminated

• Conditions: Cancer; Anaemia
• Interventions: Other: Blood transfusion

• Registration Number: NCT01116479
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haemoglobin (< normal range)	Blood transfusion	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
Haemoglobin (<6.0 mmol/l)	Blood transfusion	Blood transfusion thresholds:Haemoglobin \< 6.0 mmol/l (9.9 g/dL)

Primary Outcome Measures

Name	Time	Method
FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status	Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion	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

Secondary Outcome Measures

Name	Time	Method
Safety and transfusion complications	during or after transfusion	Frequency of complications to blood transfusion (need for termination of transfusion due to complications, chills, fever, hives, drop in blood pressure, dyspnea, other)

Trial Locations

Locations (2)

Blood bank, Righospitalet; 🇩🇰 Copenhagen, Denmark

Dept. of Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark