None listed
Conditions
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.
Interventions
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed