Ginger (Zingiber officinale) as anti-emetic prophylaxis for chemotherapy-induced nausea and vomiting

ISRCTN	ISRCTN11623624
DOI	https://doi.org/10.1186/ISRCTN11623624
Secondary identifying numbers	N0236151198

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 31/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Kerry Guile
Scientific

Oncology Dept
Jenner Wing Level 2
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Study information

Study design	Randomised controlled open-label trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Ginger (Zingiber officinale) as anti-emetic prophylaxis for chemotherapy-induced nausea and vomiting
Study objectives	To establish the antiemetic efficacy of ginger (Zingiber officinale) in addition to standard antiemetic therapy for highly emetogenic cancer chemotherapy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Nausea and vomiting
Intervention	A single supply of commercially available ginger capsules will be purchased. Patients in the study group will receive 550mg orally 3x a day for 5 days. 1st dose will be administered 1 hour prior to the first dose of chemotherapy. Trial medication will be used during the first cycle of chemotherapy only. Study protocol: The study will recruit patients receiving FEC chemotherapy or any regimen containing cisplatin at 50mg/m2 or more in a single dose. Patients will be randomly and evenly allocated into 2 groups. Group 1 - 59 patients receiving standard antiemetic therapy. Group 2 - 59 patients receiving standard therapy plus ginger. Randomisation will be performed by the Clinical Trials Support Unit, Institute of Cancer Research. Regimens: The chemotherapy unit at St George's Hospital has had a formal antiemetic policy in operation since 1998. Patients receiving FEC or cisplatin-based chemotherapy are routinely offered 'Level 4' antiemetic prophylaxis. Schedule of clinical activity: Patients will be given a diary card to record nausea and episodes of vomiting for 5 days following administration of chemotherapy. Investigators will independently record episodes of nausea or vomiting on the Case Report Form. The use of salvage antiemetics will also be noted. Both nausea and vomiting will be graded according to the NCI common toxicity criteria.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ginger (Zingiber officinale)
Primary outcome measure	Total antiemetic control (no nausea or vomiting during the study period)
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2003
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	118
Key inclusion criteria	118 cancer patients
Key exclusion criteria	1. Any prior chemotherapy 2. Anticipatory nausea/vomiting 3. Concurrent use of products containing ginger or ginger preparations 4. Concurrent use of any other experimental drugs 5. Clinical or radiological evidence of cerebral metastases 6. Clinical or radiological evidence of intestinal obstruction; any profound metabolic disturbance liable to cause nausea and vomiting (hypercalcaemia, diabetic ketoacidosis etc) 7. Any history of hypersensitivity to ginger 8. Any condition precluding the use of standard antiemetic therapy
Date of first enrolment	01/05/2003
Date of final enrolment	01/05/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St George's Hospital

London
SW17 0QT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

St George's Healthcare NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

31/03/2020: No publications found, all search options exhausted, study status unverified.