Title: ICaRAS (Intravenous Iron for Cancer Related Anaemia Symptoms) – A Feasibility Study of Intravenous Iron Therapy for Anaemia in Palliative Cancer Care
Funder: Department of Health and Social Care

Abstract: Background: Fatigue is the most common symptom in palliative care patients occuring in up to 80% of patients (Radbruch 2008). The causes of fatigue are multi-factorial. Anaemia is an important and common cause of fatigue, occurring in over two-thirds of patients in palliative care (Dunn 2003). Up to 50% of this anaemia may be related to iron deficiency (Robertson 2009). Correcting anaemia improves quality of life (Crawford 2002). Currently neither fatigue nor anaemia in palliative cancer care have specific treatments, other than treating the underlying cancer when possible. Only severe anaemia is addressed and here the mainstay of treatment is red blood cell transfusion, due to cost, limited supply and potential complications. Erythropoietin cannot be given to patients not receiving chemotherapy because of an increased risk in mortality (Bohlius 2009). New intravenous iron products are safe to deliver and offer potential for an effective treatment that can be applied where currently no treatment is given. Aims: To determine the feasibility of a phase III placebo controlled multi-centre randomised control trial of intravenous iron for anaemia and fatigue in patients undergoing palliative cancer care. Plan of investigation: This study has been designed to assess the feasibility of a larger definitive trial investigating the efficacy of intravenous iron for fatigue and anaemia in palliative cancer care. The feasibility study will randomise 40 patients with histologically proven solid tumours who are suffering from fatigue and anaemia (haemoglobin Potential benefits to patient and NHS: Despite fatigue being a very common symptom in patients with cancer it is widely under-diagnosed and under-treated in part due to a lack of effective treatments. Intravenous iron offers a new treatment where iron deficiency is the cause of fatigue and anaemia, potentially avoiding blood transfusions and improving a patient s physical, emotional and cognitive ability. This would result in better quality of life for those receiving palliative cancer care and confer health economic benefits to the NHS through decreased use of red blood cell transfusions and hospital resources.

Lay abstract: Aim: To determine the feasibility of improving anaemia in patients with incurable cancer by iron supplements. Background: Anaemia ( low red blood count) is common in patients with incurable cancer. It means that cells in the body cannot get enough oxygen, and significantly worsens the fatigue that is associated with the illness. Ability to carry out even basic daily activities is reduced, and so quality of life is further restricted. There is no specific treatments at present. Only severe anaemia is treated with blood transfusions because of limited availability and high expense. Our study looks to see whether an iron infusion (a method to get iron into the blood quicker) can help improve anaemia and tiredness in patients with incurable cancer. New iron infusions can be given safely and offer potential treatment where at present no treatment is given. Iron infusion works by replacing iron in the body that became low from cancer. With this treatment the body can then make new red blood cells to replace those lost, and therefore improve anaemia and tiredness. Design and methods used: In this study we will look at whether it is feasible to recruit and treat people with incurable cancer suffering from anaemia and tiredness. Patients will be randomly assigned to receive either the iron infusion or usual care. Patients will have blood tests and complete questionnaires that assess quality of life and what symptoms they suffered from before starting treatment. They will repeat tests at 4 and 8 weeks to see how effective the treatment has been. Patient and public involvement: Patients are members of the team writing this research funding application. They will be involved in the study through design to reporting what we found. Dissemination: Our results will be shared with posters, presentations and be published in medical journals.

Research activity codes: 7.2 END OF LIFE CARE;6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS;BLOOD