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

Introduction
There is significant recent interest in the role of ginger root (Zingiber officinale)
as an adjuvant therapy for chemotherapy-induced nausea and vomiting.
Objectives
This study protocol aims to assess the efficacy (reduced incidence and
severity of chemotherapy-induced nausea and vomiting, enhanced quality
of life), safety, cost-effectiveness, and impact on gut microbiota of a
standardized adjuvant ginger root supplement in adults undergoing
single-day moderate-to-highly emetogenic chemotherapy.
Methods
Multi-site, double-blind, placebo-controlled randomized trial with two parallel
arms, 1:1 allocation and target sample size of N=300. The intervention
comprises four capsules of ginger root consumed at specified times across the
day (totaling 60mg of active gingerols/day), for five consecutive days commencing
on the day of chemotherapy forCycles 1 to 3. The primary outcome
is chemotherapy-induced nausea-related quality of life measured by the
Functional Living Index – Emesis – 5 Day Recall (FLIE-5DR). 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. Changes to the microbiome will be examined using 16S RNA
analysis. Adverse events and adherence will also be assessed.
Results
The SPICE trial commenced recruitment in October 2017 and is anticipated
to continue until October 2019. To date, 25 participants have been
recruited and the study appears feasible.
Conclusions
The research gaps addressed by the SPICE Trial may guide future recommendations
for specific ginger dosing regimens for use as an adjuvant for
chemotherapy induced nausea and vomiting prevention and management.