Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Kerry Guile

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236151198

Study information

Scientific title

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

Acronym

Study hypothesis

To establish the antiemetic efficacy of ginger (Zingiber officinale) in addition to standard antiemetic therapy for highly emetogenic cancer chemotherapy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled open-label trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Ginger (Zingiber officinale)

Primary outcome measures

Total antiemetic control (no nausea or vomiting during the study period)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2003

Overall trial end date

01/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

118 cancer patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

118

Participant 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

Recruitment start date

01/05/2003

Recruitment end date

01/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's Hospital
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes