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

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

Research output: Contribution to journalMeeting AbstractResearchpeer-review

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Abstract

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.
Original languageEnglish
Article numbereP245
Pages (from-to)S169
JournalSupportive Care in Cancer
Volume26
Issue numberS2
DOIs
Publication statusPublished - Jun 2018
EventMultinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO): MASCC/ISOO 2018 Annual Meeting on Supportive Care in Cancer - Vienna, Austria
Duration: 28 Jun 201830 Jun 2018
https://masccmeeting.org/2018#.XLwQPugzaUk

Fingerprint

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

Cite this

@article{c682d6eddefa4c11a433109772ea8320,
title = "Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (spice) trial: Protocol for a multi-centre double-blind placebo-controlled randomized trial",
abstract = "IntroductionThere is significant recent interest in the role of ginger root (Zingiber officinale)as an adjuvant therapy for chemotherapy-induced nausea and vomiting.ObjectivesThis study protocol aims to assess the efficacy (reduced incidence andseverity of chemotherapy-induced nausea and vomiting, enhanced qualityof life), safety, cost-effectiveness, and impact on gut microbiota of astandardized adjuvant ginger root supplement in adults undergoingsingle-day moderate-to-highly emetogenic chemotherapy.MethodsMulti-site, double-blind, placebo-controlled randomized trial with two parallelarms, 1:1 allocation and target sample size of N=300. The interventioncomprises four capsules of ginger root consumed at specified times across theday (totaling 60mg of active gingerols/day), for five consecutive days commencingon the day of chemotherapy forCycles 1 to 3. The primary outcomeis chemotherapy-induced nausea-related quality of life measured by theFunctional Living Index – Emesis – 5 Day Recall (FLIE-5DR). Secondaryoutcomes include nutrition status; anticipatory, acute and delayed nausea andvomiting; fatigue; depression and anxiety; global quality of life; health serviceuse and costs. Changes to the microbiome will be examined using 16S RNAanalysis. Adverse events and adherence will also be assessed.ResultsThe SPICE trial commenced recruitment in October 2017 and is anticipatedto continue until October 2019. To date, 25 participants have beenrecruited and the study appears feasible.ConclusionsThe research gaps addressed by the SPICE Trial may guide future recommendationsfor specific ginger dosing regimens for use as an adjuvant forchemotherapy induced nausea and vomiting prevention and management.",
author = "Megan Crichton and Wolfgang Marx and Alexandra McCarthy and Skye Marshall and Alex Molassiotis and Karin Ried and Robert Bird and Lohning, {Anna Elizabeth} and Elisabeth Isenring",
year = "2018",
month = "6",
doi = "10.1007/s00520-018-4193-2",
language = "English",
volume = "26",
pages = "S169",
journal = "Supportive Care in Cancer",
issn = "0941-4355",
publisher = "Springer",
number = "S2",

}

Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (spice) trial: Protocol for a multi-centre double-blind placebo-controlled randomized trial. / Crichton, Megan; Marx, Wolfgang; McCarthy, Alexandra; Marshall, Skye; Molassiotis, Alex; Ried, Karin; Bird, Robert; Lohning, Anna Elizabeth; Isenring, Elisabeth.

In: Supportive Care in Cancer, Vol. 26, No. S2, eP245, 06.2018, p. S169.

Research output: Contribution to journalMeeting AbstractResearchpeer-review

TY - JOUR

T1 - Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (spice) trial: Protocol for a multi-centre double-blind placebo-controlled randomized trial

AU - Crichton, Megan

AU - Marx, Wolfgang

AU - McCarthy, Alexandra

AU - Marshall, Skye

AU - Molassiotis, Alex

AU - Ried, Karin

AU - Bird, Robert

AU - Lohning, Anna Elizabeth

AU - Isenring, Elisabeth

PY - 2018/6

Y1 - 2018/6

N2 - IntroductionThere is significant recent interest in the role of ginger root (Zingiber officinale)as an adjuvant therapy for chemotherapy-induced nausea and vomiting.ObjectivesThis study protocol aims to assess the efficacy (reduced incidence andseverity of chemotherapy-induced nausea and vomiting, enhanced qualityof life), safety, cost-effectiveness, and impact on gut microbiota of astandardized adjuvant ginger root supplement in adults undergoingsingle-day moderate-to-highly emetogenic chemotherapy.MethodsMulti-site, double-blind, placebo-controlled randomized trial with two parallelarms, 1:1 allocation and target sample size of N=300. The interventioncomprises four capsules of ginger root consumed at specified times across theday (totaling 60mg of active gingerols/day), for five consecutive days commencingon the day of chemotherapy forCycles 1 to 3. The primary outcomeis chemotherapy-induced nausea-related quality of life measured by theFunctional Living Index – Emesis – 5 Day Recall (FLIE-5DR). Secondaryoutcomes include nutrition status; anticipatory, acute and delayed nausea andvomiting; fatigue; depression and anxiety; global quality of life; health serviceuse and costs. Changes to the microbiome will be examined using 16S RNAanalysis. Adverse events and adherence will also be assessed.ResultsThe SPICE trial commenced recruitment in October 2017 and is anticipatedto continue until October 2019. To date, 25 participants have beenrecruited and the study appears feasible.ConclusionsThe research gaps addressed by the SPICE Trial may guide future recommendationsfor specific ginger dosing regimens for use as an adjuvant forchemotherapy induced nausea and vomiting prevention and management.

AB - IntroductionThere is significant recent interest in the role of ginger root (Zingiber officinale)as an adjuvant therapy for chemotherapy-induced nausea and vomiting.ObjectivesThis study protocol aims to assess the efficacy (reduced incidence andseverity of chemotherapy-induced nausea and vomiting, enhanced qualityof life), safety, cost-effectiveness, and impact on gut microbiota of astandardized adjuvant ginger root supplement in adults undergoingsingle-day moderate-to-highly emetogenic chemotherapy.MethodsMulti-site, double-blind, placebo-controlled randomized trial with two parallelarms, 1:1 allocation and target sample size of N=300. The interventioncomprises four capsules of ginger root consumed at specified times across theday (totaling 60mg of active gingerols/day), for five consecutive days commencingon the day of chemotherapy forCycles 1 to 3. The primary outcomeis chemotherapy-induced nausea-related quality of life measured by theFunctional Living Index – Emesis – 5 Day Recall (FLIE-5DR). Secondaryoutcomes include nutrition status; anticipatory, acute and delayed nausea andvomiting; fatigue; depression and anxiety; global quality of life; health serviceuse and costs. Changes to the microbiome will be examined using 16S RNAanalysis. Adverse events and adherence will also be assessed.ResultsThe SPICE trial commenced recruitment in October 2017 and is anticipatedto continue until October 2019. To date, 25 participants have beenrecruited and the study appears feasible.ConclusionsThe research gaps addressed by the SPICE Trial may guide future recommendationsfor specific ginger dosing regimens for use as an adjuvant forchemotherapy induced nausea and vomiting prevention and management.

U2 - 10.1007/s00520-018-4193-2

DO - 10.1007/s00520-018-4193-2

M3 - Meeting Abstract

VL - 26

SP - S169

JO - Supportive Care in Cancer

JF - Supportive Care in Cancer

SN - 0941-4355

IS - S2

M1 - eP245

ER -