Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (SPICE) trial: Protocol for a multicentre double-blind placebo-controlled randomised trial

AimThere is significant recent interest in the role of ginger root (Zingiber officinale) as an adjuvant therapy for chemotherapy-induced nausea. The supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (SPICE) trial aims to assess the efficacy by reduced incidence and severity of chemotherapy-induced nausea and vomiting, and enhanced quality of life, safety and cost effectiveness of a standardised adjuvant ginger root supplement in adults undergoing single-day moderate-to-highly emetogenic chemotherapy. MethodsMultisite, double-blind, placebo-controlled randomised trial with two parallel arms and 1:1 allocation. The target sample size is n=300. The intervention comprises four capsules of ginger root (totalling 60mg of active gingerols/day), commencing the day of chemotherapy and continuing for five days during chemotherapy cycles 1 to 3. The primary outcome is chemotherapy-induced nausea-related quality of life. Secondary outcomes include nutrition status; anticipatory, acute and delayed nausea and vomiting; fatigue; depression and anxiety; global quality of life; health service use and costs; adverse events; and adherence. ResultsDuring the five-month recruitment period from October 2017 to April 2018 at site A only, a total of n=33 participants (n=18 female) have been enrolled in the SPICE trial. Recruitment is expected to commence at Site B in May 2018. ConclusionsThe trial is designed to meet research gaps and could provide evidence to recommend specific dosing regimens as an adjuvant for chemotherapy-induced nausea and vomiting prevention and management.