What this study adds
iron deficiency, fatigue
IRON DEFICIENCY, ADVANCED CANCER
The study has demonstrated that it is feasible to recruit people to a randomised
controlled trial of intravenous iron according to our enrolment of 1–4
participants per month. The participant attrition rate was also in keeping with
the rate proposed in our protocol at 25%. Further, the feasibility target of 30
participants was also passedChanges seen in haemoglobin with iron offer an important objective measures
through which clinicians might evaluate treatment response among recipients and
will guide future trial design. Similar, retrospective, uncontrolled studies of
iron therapy in people with iron deficiency receiving palliative care have
reported higher haemoglobin increases of 15.1–18.7 g/L over 4–8 weeks following
iron infusionA positive correlation was seen between haemoglobin rise and selected quality of
life domains such as the FACT-G derived score. This highlights an area for
further evaluation given that previous studies suggest that only a weak
correlation might exist.Quality of life reporting should be seen as the most important participant
centred outcome, and this is likely to represent the most meaningful primary
outcome measure in a definitive trial. ICaRAS was not powered to detect
clinically meaningful changes in quality of life but there is an indication that
intravenous iron may offer favourable improvements for participants compared to
placebo for the FACIT-F fatigue scale. The FACIT-F has been widely studied among
similar participant populations and has been used as a primary outcome measure
in contemporary trials of treatments for fatigue in people with advanced
cancerThe observations seen in fatigue scale scores for placebo group participants
indicated an increase in fatigue over the 8 weeks. These data support the
understanding of a functional decline in people with advanced cancer,
particularly in the last year of life.