Chemotherapy-induced nausea and vomiting from oral chemotherapy for childhood acute lymphoblastic leukaemia: feasibility study

Abstract

ObjectiveTo 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.MethodsEnglish-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.ResultsTwenty-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.ConclusionsA 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.

Translation of the Pediatric Nausea Assessment Tool (PeNAT) Into Spanish and Evaluating Understandability Among Spanish-Speaking Hispanic American Children and Adolescents Receiving Chemotherapy

“…The PeNAT has been used to measure nausea severity in several pediatric studies (Carroll et al, 2018; Flank, Nadeem, Khanna et al, 2017; Flank et al, 2018; Flank, Sparavalo, Vol et al, 2017; Kovacevic et al, 2019). All were restricted to English-speaking patients and families.…”

“…Adult cancer patients, pediatric cancer patients, and parents of pediatric cancer patients consistently rank chemotherapyinduced nausea and vomiting (CINV) among the most bothersome adverse effects that they or their children experience (Carelle et al, 2002;Coates et al, 1983;Dupuis, Johnston, et al, 2018;Dupuis et al, 2010). Although not yet optimized, vomiting control has improved considerably due to new antiemetic agents and the availability of clinical practice guidelines (Patel et al, 2017). Chemotherapy-induced nausea, however, remains prevalent and bothersome (Dupuis, Kelly, et al, 2018;Kovacevic et al, 2019).…”

“…Although not yet optimized, vomiting control has improved considerably due to new antiemetic agents and the availability of clinical practice guidelines (Patel et al, 2017). Chemotherapy-induced nausea, however, remains prevalent and bothersome (Dupuis, Kelly, et al, 2018; Kovacevic et al, 2019).…”

Perceptions of parents of pediatric patients with acute lymphoblastic leukemia on oral chemotherapy administration: A qualitative analysis

“…6 Detailed methods relating to the primary study have been published. 5 This study was approved by the SickKids' Research Ethics Board.…”

“…We previously reported the feasibility of a prospective study to improve nausea control among pediatric patients with ALL receiving oral chemotherapy. 5 Here, we report the findings of the secondary aims of that study to describe parents' experience in giving oral chemotherapy at home and to identify barriers, including chemotherapy-induced nausea and vomiting (CINV), and facilitators to adherence.…”