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

摘要

Aim: There 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. Methods: Multisite, 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 60 mg of active gin-gerols/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. Results: During the five-month recruitment period from October 201 7 to April 201 8 at site A only, a total of n = 33 participants (n = 1 8 female) have been enrolled in the SPICE trial. Recruitment is expected to commence at Site B in May 201 8. Conclusions: The 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.