Ginger (Zingiber officinale) as anti-emetic prophylaxis for chemotherapy-induced nausea and vomiting
| ISRCTN | ISRCTN11623624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11623624 |
| Protocol serial number | N0236151198 |
| Sponsor | Department of Health |
| Funder | St George's Healthcare NHS Trust (UK), NHS R&D Support Funding |
- 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
Scientific
Oncology Dept
Jenner Wing Level 2
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled open-label trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ginger (Zingiber officinale) |
| Primary outcome measure(s) |
Total antiemetic control (no nausea or vomiting during the study period) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
St George's Hospital
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
31/03/2020: No publications found, all search options exhausted, study status unverified.
