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

Cancer Clinical Trial

— HaemOPtimal  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01116479
• Other study ID #: H-1-2009-109
• Status: Terminated
• Phase: Phase 2
• First received: April 28, 2010
• Last updated: November 3, 2014
• Start date: March 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Anaemia
• Cancer

Intervention

Other:
• Blood transfusion
Blood transfusion with packed erythrocytes

Locations

Country	Name	City	State
Denmark	Blood bank, Righospitalet	Copenhagen
Denmark	Dept. of Oncology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes