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

Wolfgang Marx, Alexandra L. McCarthy, Skye Marshall, Megan Crichton, Alex Molassiotis, Karin Ried, Robert Bird, Anna Lohning, Elizabeth Isenring

Research output: Contribution to journalArticleResearchpeer-review

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)144-150
Number of pages7
JournalNutrition and Dietetics
Volume77
Issue number1
Early online date23 Jul 2018
DOIs
Publication statusPublished - 1 Feb 2020

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