Background Nausea and vomiting (N and V) are common, debilitating symptoms in patients with cancer, often precipitating inpatient admission for subcutaneous/intravenous antiemetics and re-hydration. Currently, there are no evidence-based solutions and treatment algorithms differ across clinical practice. Some of these patients will experience difficulty swallowing tablets and/or are unable to keep oral medications down. Treatments for patients with cancer may also reduce the ability of the intestines to absorb medicines within a tablet.
SANCUSO® (Granisetron Transdermal System [transdermal skin patch]) is indicated for the prevention of (N and V) in patients receiving moderately and/or highly emetogenic chemotherapy regimens. The SANCUSO® patch delivers consistent, predictable levels of granisetron throughout five days with smoother daily pharmacokinetics compared to daily dosing. The role of Sancuso in patients with cancer and refractory N and V which is unrelated to chemotherapy has not been explored.
Methods An open-label, randomised feasibility study comparing Sancuso with ‘physician’s choice’ of antiemetic in patients with cancer and refractory N and V. A feasibility study is required at this juncture as standard antiemetic treatment in this patient population is undefined, and the therapeutic efficacy of Sancuso requires appraisal before embarking on a larger randomised trial. To assess feasibility, objectives have been categorised into the four domains; (i) Recruitment - assess the number of patients approached, consent rate, number of eligible patients and explore the methods used to identify potential patients (ii) Patients - willingness to participate and acceptability of the intervention (iii) Clinicians’ - ability to recruit, which physician’s choice is selected, experience including monitoring of prescribing practice in the control arm (iv) Trial procedures - determine the appropriate primary outcome, adherence/compliance rates
Implications We aim to determine whether this approach is feasible and warrants further investigation in a larger randomised Phase II trial leading to a confirmatory multi-centre randomised Phase III trial to include a cost-effectiveness appraisal.
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