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

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
JournalNutrition and Dietetics
DOIs
Publication statusE-pub ahead of print - 23 Jul 2018

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Clinical Protocols
Nausea
Vomiting
Randomized Controlled Trials
Ginger
Placebos
Drug Therapy
Quality of Life
Adjuvant Chemotherapy
Nutritional Status
Health Care Costs
Sample Size
Health Services
Cost-Benefit Analysis
Capsules
Fatigue
Anxiety
Depression
Safety
Incidence

Cite this

@article{abaac41a54034e77a6aa4ccf76166211,
title = "Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (SPICE) trial: Protocol for a multicentre double-blind placebo-controlled randomised 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.",
author = "Wolfgang Marx and McCarthy, {Alexandra L.} and Skye Marshall and Megan Crichton and Alex Molassiotis and Karin Ried and Robert Bird and Anna Lohning and Elizabeth Isenring",
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Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (SPICE) trial : Protocol for a multicentre double-blind placebo-controlled randomised trial. / Marx, Wolfgang; McCarthy, Alexandra L.; Marshall, Skye; Crichton, Megan; Molassiotis, Alex; Ried, Karin; Bird, Robert; Lohning, Anna; Isenring, Elizabeth.

In: Nutrition and Dietetics, 23.07.2018.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (SPICE) trial

T2 - Protocol for a multicentre double-blind placebo-controlled randomised trial

AU - Marx, Wolfgang

AU - McCarthy, Alexandra L.

AU - Marshall, Skye

AU - Crichton, Megan

AU - Molassiotis, Alex

AU - Ried, Karin

AU - Bird, Robert

AU - Lohning, Anna

AU - Isenring, Elizabeth

N1 - © 2018 Dietitians Association of Australia.

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Y1 - 2018/7/23

N2 - 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.

AB - 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.

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DO - 10.1111/1747-0080.12446

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JO - Nutrition and Dietetics

JF - Nutrition and Dietetics

SN - 1032-1322

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