ICaRAS: Intravenous Iron for Cancer Related Anaemia Symptoms

Trial Overview

Acronym	ICaRAS
Number	ISRCTN 13370767
Protocol Link	http://www.isrctn.com/ISRCTN13370767
Public Trial Registry Link	https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-001669-17/GB
Status	Open/recruiting
Category	Colorectal Cancer - All
Treatment Course	Adjuvant, palliative or post-op

Trial Description

ICaRAS is a randomised placebo controlled trial evaluating intravenous iron therapy as a solution to anaemia in palliative cancer. The study will focus on important outcome measures for these patients such as improving fatigue, activity levels and quality of life. Cancer related anaemia, often secondary to a depletion or dysregulation of iron stores, contributes significantly to the disability of palliative cancer patients. Current treatment options such as oral iron tablets and blood transfusio

Chief Investigator

Austin Acheson
Associate Professon

Profile Link

Lead Centre

Nottingham University Hospitals
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Website

Collaboration and Funding

Funding Sponsors

Additional Information

Full Research Summary

Objective:	Currently there is no evidence relating to the use of intravenous iron in palliative cancer care to manage anaemia and its related symptoms. Existing methods such as oral iron tablets or blood transfusions may be ineffective and offer only short term benefits. Through this study we will evaluate the use of intravenous iron as a potential solution to this anaemia. We will be particularly focused on outcome measure important to this patient population such as fatigue, physical wellbeing and quality of life.
Aim:	ICaRAS aims to evaluate the use of intravenous iron as a solution to cancer related anaemia in patients undergoing palliative management. The study is currently running as a multicentre pilot but we would welcome expressions of interest from other sites for the future definitive trial.
Methods:	Recruited participants will be invited to complete quality of life questionnaires and to wear a FitBit pedometer for a week to assess activity levels prior to their infusion. They will also undertake a short physical assessment (the Short Physical Performance Battery) at this timepoint. Patients will then be randomised in a double blind fashion to receive either a dose of intravenous iron isomaltoside (according to manufacturers recommendations) or placebo (0.9% saline). Follow up is then conducted at 4 weeks and 8 weeks after their infusion. At both follow up visits blood tests, questionnaires and the physical assessment will be repeated. Participants will also be asked to wear the FitBit once more for a week prior to the two follow up visits.
Reason for International Trial:	ICaRAS is currently running as a pilot but we would like to invite expressions of interest from any centre wishing to support the study in the future.