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

Area of Science:

• Pediatric Oncology
• Clinical Trial Design
• Supportive Care

Background:

• Chemotherapy-induced nausea and vomiting (CINV) is a significant challenge for pediatric patients undergoing treatment for acute lymphoblastic leukemia (ALL).
• Oral chemotherapy during ALL maintenance therapy requires effective CINV management strategies.
• Evaluating the feasibility of prospective trials is crucial for advancing CINV control in this population.

Purpose of the Study:

• To assess the feasibility of a large prospective trial focused on enhancing CINV control in pediatric patients receiving oral chemotherapy for ALL maintenance.
• To determine if the proposed trial design meets predefined feasibility benchmarks for patient enrollment and data collection.

Main Methods:

• An observational, serial, cross-sectional feasibility study was conducted with English-speaking children aged 4.0-17.99 years undergoing ALL maintenance.
• Data were collected over one to three 7-day periods during specific months of maintenance therapy.
• Feasibility was defined by the time to enroll 10 patients per period (≤1 year) and ≥80% evaluable data return.

Main Results:

• Twenty-nine of 31 eligible patients completed the study, with recruitment taking 1.2 years to enroll 29 patients.
• Evaluable data were obtained from 72% of patients in each of the three data collection periods.
• Complete CINV control was reported in 29% of evaluable study periods.

Conclusions:

• The current study design is not feasible for a large prospective trial to improve CINV control in pediatric ALL patients on oral maintenance chemotherapy.
• Recommendations for future trials include implementing electronic data capture and initiating patient recruitment in the mid- to late-maintenance phase of therapy.