Main findings
anaemia, fatigue
ANAEMIA, ADVANCED CANCER, RECRUITMENT, SECONDARY, EVENTS
The ICaRAS trial has demonstrated that intravenous iron administration was
feasible and well tolerated in people with advanced cancer being managed in a
palliative setting according to recruitment and attrition rates. The chosen
research questions were all assessed via the feasibility outcomes and the
results of the trial now act as a guide for the design of a definitive study.
The direction of effect in our secondary outcome measures suggests that
intravenous iron may be an efficacious means of improving haemoglobin compared
to placebo in this group of people. These changes were sustained until at least
8 weeks after treatment and anaemia resolution was achieved in a higher
proportion of participants in the intravenous iron group. We also found that
changes in ferritin and transferrin saturation follow similar trends to those
seen in the literatureThe three quality of life questionnaires were acceptable and feasible within the
present study design and the successful blinding of participants to their study
allocation further adds validity. Despite our small sample size there was a
signal that threshold of the minimum clinically important difference across
several quality of life measures was passed for participants in the iron group.
Namely, the fatigue scales of both the FACIT-F and QLQC30 as well as the FACIT-F
Trial Outcome Index.It was not possible to draw any meaningful conclusions on the impact of
intravenous iron on the frequency of blood transfusion in this group of people,
but it is encouraging that no transfusion events occurred in the iron group.
Further data are needed to examine this observation.