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

November 3, 2014 updated by: Morten Sorensen, Rigshospitalet, Denmark

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Blood bank, Righospitalet
      • Copenhagen, Denmark, DK-2100
        • Dept. of Oncology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status
Time Frame: 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
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
Time Frame: 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)
during or after transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Morten Sorensen, MD, Phd, Dept. of Oncology, Righospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2009-109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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