Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000120774
Ethics application status
Approved
Date submitted
23/01/2013
Date registered
31/01/2013
Date last updated
30/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can ginger ameliorate chemotherapy-induced nausea? A double blind, randomised placebo controlled feasibility study.
Scientific title
Can ginger ameliorate chemotherapy-induced nausea? A double blind, randomised placebo controlled feasibility study.
Secondary ID [1] 281660 0
Nil
Universal Trial Number (UTN)
Trial acronym
2012 CINV Ginger RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-induced nausea and vomiting 287949 0
Condition category
Condition code
Diet and Nutrition 288333 288333 0 0
Other diet and nutrition disorders
Cancer 288570 288570 0 0
Any cancer
Oral and Gastrointestinal 288571 288571 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.2g standardised Ginger (Zingiber officinale) extract in capsule form. Frequency: 4x300mg capsules (1.2g total) per day, every 3-5 hours. Duration: 5 days per chemotherapy cycle (Day of chemotherapy and 4 days directly after) for three 3 cycles. Initial dose is 1 hour before chemotherapy commences.
Intervention code [1] 286198 0
Treatment: Other
Comparator / control treatment
Identical placebo capsules
Control group
Placebo

Outcomes
Primary outcome [1] 288499 0
Chemotherapy-induced nausea related Quality of Life using the Functional Living Index - Emesis 5 day recall
Timepoint [1] 288499 0
24 hours post-chemotherapy(acute nausea) and 4 days post-chemotherapy (delayed nausea)
Secondary outcome [1] 300328 0
Quality of Life as assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) tool.
Timepoint [1] 300328 0
Baseline and 4 days post-chemotherapy for each cycle examined.
Secondary outcome [2] 300841 0
Adequacy of supplement blinding through patient interview post-treatment
Timepoint [2] 300841 0
4-5 days post-chemotherapy for each cycle examined.
Secondary outcome [3] 300842 0
Level and change in nutrition status using the Patient Generated Subjective Global Assessment (PG-SGA) tool.
Timepoint [3] 300842 0
The week before each chemotherapy cycle.
Secondary outcome [4] 300843 0
Incidence and severity of symptoms associated with treatment using the Edmontons Symptoms Assessment Scale (ESAS).
Timepoint [4] 300843 0
Baseline and 4 days post-chemotherapyfor each cycle examined.
Secondary outcome [5] 300844 0
The severity and frequency of nausea and vomiting as assessed using the Rhodes Index of Nausea, Vomiting and Retching tool.
Timepoint [5] 300844 0
24 hours post-chemotherapy (acute vomiting) and 4 days post-chemotherapy (delayed vomiting)
Secondary outcome [6] 300845 0
Adherence to intervention by counting unconsumed capsules and by an adherence form completed by the participant.
Timepoint [6] 300845 0
4 days post-chemotherapy.
Secondary outcome [7] 300846 0
Influence of previously identified factors that influence the generation of CINV using a 6 item questionnaire based on previously identified CINV risk factors
Timepoint [7] 300846 0
Within 3 days before the initial chemotherapy session commences.

Eligibility
Key inclusion criteria
* Chemotherapy-naive cancer patients receiving treatment of any emetogenicity.
( Previously experienced CINV symptoms in >=1 chemotherapy cycle.
* >18 years .
* Life expectancy >3 months.
* Baseline Karnofsky > 60.
* No concurrent neoplasms or illness inducing nausea independent of chemotherapy
* No self-prescribed therapies for nausea.
* Receiving moderate or highly emetogenic chemotherapy treatment.
* Receiving 5HT3 antagonist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will apply:
* Patients requiring radiotherapy.
* Pregnant or lactating.
* Concurrent use of other ginger-containing supplements and ingestion of large quantities of ginger.
* History of adverse reactions to ginger.
* Patients with malignancies of gastrointestinal tract/gastrointestinal diseases or nausea and vomiting due to reasons other than chemotherapy.
* Thrombocytopenia or patients undergoing chemotherapy that is likely to cause thrombocyopenia (<50 x 10^9/L).
* Currently prescribed warfarin or on anti-coagulant therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The research dietitian will allocate participants based on instructions from the principle investigator who will not make direct contact with the participant during this process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be generated using computer software and participants will be stratified according to emetogenicity of prescribed chemotherapy and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics
Baseline characteristics were compared between groups using independent t-test analysis for continuous variables and chi-square or Fisher’s exact test for categorical variables.
Study intervention
Between-group (ginger vs placebo) comparisons were performed using independent-samples t-test for quantitative variables. Chi-square and Fisher’s exact test was performed for categorical variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/06/2013
Actual
13/05/2014
Date of last participant enrolment
Anticipated
26/12/2014
Actual
17/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
77
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 468 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 6219 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 286456 0
Government body
Name [1] 286456 0
Queensland Health. Health Practitioners Research Scheme Grant.
Country [1] 286456 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland,
St Lucia, QLD, 4067
Country
Australia
Secondary sponsor category [1] 285243 0
None
Name [1] 285243 0
Address [1] 285243 0
Country [1] 285243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288533 0
Metro South HREC
Ethics committee address [1] 288533 0
Metro South Hospital and Health Service
Human Research Ethics Committee (EC00167)
Centres for Health Research
Princess Alexandra Hospital
Woolloongabba QLD 4102, Australia
Ethics committee country [1] 288533 0
Australia
Date submitted for ethics approval [1] 288533 0
15/11/2012
Approval date [1] 288533 0
30/01/2013
Ethics approval number [1] 288533 0
EC00167

Summary
Brief summary
This study aims to determine whether ginger can reduce chemotherapy-induced nausea and vomiting. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and you are scheduled to undergo chemotherapy for the first time. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take 4 ginger capsules per day, commencing 1 hour before chemotherapy and then every 3-5 hours for 4 days directly after. This will be repeated for 3 chemotherapy cycles. Participants in the other group will take an identical-looking sham tablet, i.e. one that has no active ingredients. Participants will not know whether they are taking the ginger or sham tablets until the end of the trial. All participants will be assessed over the 4 days post each chemotherapy session in order to determine: 1) the effect of ginger on chemotherapy-induced nausea; 2) the tolerability of ginger to chemotherapy patients when used alongside standard anti-nausea medication; and 3) the feasibility of introducing it in our clinical setting.
Trial website
Trial related presentations / publications
Publication in progress
Public notes

Contacts
Principal investigator
Name 36566 0
Dr Elizabeth Isenring
Address 36566 0
Department of Dietetic Studies, School of Human Movement Studies, The University of Queensland, St Lucia, 4067, QLD
Country 36566 0
Australia
Phone 36566 0
+61733656982
Fax 36566 0
Email 36566 0
[email protected]
Contact person for public queries
Name 36567 0
Elizabeth Isenring
Address 36567 0
Department of Dietetic Studies, School of Human Movement Studies, The University of Queensland, St Lucia, 4067, QLD
Country 36567 0
Australia
Phone 36567 0
+61733656982
Fax 36567 0
Email 36567 0
[email protected]
Contact person for scientific queries
Name 36568 0
Elizabeth Isenring
Address 36568 0
Department of Dietetic Studies, School of Human Movement Studies, The University of Queensland, St Lucia, 4067, QLD
Country 36568 0
Australia
Phone 36568 0
+61733656982
Fax 36568 0
Email 36568 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of a standardized ginger extract on chemotherapy-induced nausea-related quality of life in patients undergoing moderately or highly emetogenic chemotherapy: A double blind, randomized, placebo controlled trial.2017https://dx.doi.org/10.3390/nu9080867
N.B. These documents automatically identified may not have been verified by the study sponsor.