Background Opioid-induced constipation (OIC) is frequently undertreated in patients with advanced cancer. Our hypothesis is that the use of a stepwise treatment algorithm, supported by regular patient-reported outcome measures, should improve the management of OIC. The aim of this feasibility study was to determine whether a definitive study could be successfully completed.
Methods Patients with OIC (Rome Foundation diagnostic criteria positive), and a Bowel Function Index (BFI) score of ≥30, were recruited to the study. The study involved weekly assessments, and decisions about management were based on the current BFI score (and the tolerability of the current treatment). Management was based on a four-step treatment algorithm, developed from recent international guidelines.
Results One hundred patients entered the study, and 79 patients completed the study. Fifty-seven (72%) participants responded to treatment, with 34 (43%) participants having a ‘complete’ response (ie, final BFI<30) and 23 (29%) participants having a ‘partial’ response (ie, change in BFI≥12). In participants with a complete response, 73.5% were prescribed conventional laxatives, 12% were prescribed a peripherally acting mu-opioid receptor antagonist (PAMORA) and 14.5% were prescribed a PAMORA and conventional laxative.
Discussion The feasibility study suggests that a definitive study can be successfully completed. However, we will amend the methodology to try to improve participant recruitment, participant retention and adherence to the treatment algorithm. The feasibility study also suggests that the use of the BFI to monitor OIC, and the use of a treatment algorithm to manage OIC, can result in clinically important improvements in OIC.
Trial registration number
Data availability statement
Data will be made available to other researchers on request.
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Contributors AND conceived the study, and was the chief investigator. KB was the study statistician. All other authors were principal investigators, and everyone contributed to the writing of the paper.
Competing interests AND and CL have both received personal fees for consultancy/educational activities from Kyowa Kirin International. None of the other authors have relevant conflicts of interest.
Provenance and peer review Not commissioned; externally peer reviewed.