Objective To evaluate the feasibility of a large prospective trial aimed at improving chemotherapy-induced nausea and vomiting (CINV) control in paediatric patients undergoing oral chemotherapy during acute lymphoblastic leukaemia (ALL) maintenance therapy.
Methods English-speaking children, 4.0–17.99 years old and undergoing ALL maintenance treatment with an English-speaking guardian, were eligible to participate in this observational, serial, cross-sectional feasibility study. Data were collected from participants over one to three 7-day periods during months 2–3, 5–6 and 11–12 of ALL maintenance treatment. A future trial was considered feasible if the mean time to enrol 10 patients in each of three data collection periods was ≤1 year with ≥80% of patients returning evaluable data. CINV control was described as a secondary endpoint.
Results Twenty-nine of 31 consenting patients (median age: 6.5 years, IQR: 5.1–9.2) completed the study: 10 in months 2–3, 10 in months 5–6 and 9 in months 11–12. The total time to recruit 29 patients was 1.2 years. In each of the three data collections periods, 72% of the patients provided evaluable data. Complete CINV control was reported in 6/21 (29%) evaluable study periods.
Conclusions A future trial to evaluate interventions to improve CINV control in patients with ALL undergoing oral maintenance chemotherapy as designed in this study is not feasible. An electronic data capture method and deferring patient recruitment until the mid-maintenance to late-maintenance phase should be considered in the design of a future trial.
- nausea and vomiting
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Contributors AK, SA, LS and LLD conceived and designed the study; AK, AS, RP, PP, AV, EPCS and SZ collected the data; AK and LLD analysed the data and wrote the paper; AS, RP, PP, AV, EPCS, SZ, SA and LS reviewed the paper and provided critical comments; and AK, AS, RP, PP, AV, EPCS, SZ, SA, LS and LLD reviewed and approved the final submission:
Funding The funding support of the Department of Pharmacy, SickKids is gratefully acknowledged.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon request.
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