Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (spice) trial: Protocol for a multi-centre double-blind placebo-controlled randomized trial

Abstract

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 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. Results: During 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. 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.No Full Tex