|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 April 2016 |
|
Main ID: |
NCT02390648 |
|
Date of registration:
|
11/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting
|
|
Scientific title:
|
Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting: Randomised Double-blind Placebo-control Cross Over Study |
|
Date of first enrolment:
|
March 2015 |
|
Target sample size:
|
34 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02390648 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Thailand
| | | | | | | |
|
Contacts
|
|
Name:
|
Nopadol Soparattanapaisarn, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Lecturer |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Histologically or cytologically confirmed breast cancer patient
- Received AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) and has nausea
score at least 40/100 VAS or has vomiting
- Expect to receive at least 2 further cycles of AC regimen chemotherapy
- Provide informed consent
Exclusion Criteria:
- Pregnancy or lactation
- Has nausea or vomiting during 24 hours before chemotherapy
- Has other causes of nausea or vomiting eg. brain metastasis, gut obstruction,
hepatitis or recent abdominal or pelvic irradiation within 1 week before chemotherapy
- Received any chemotherapy regimen other than AC regimen
- Allergic or intolerance to ginger
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chemotherapy-induced Nausea and Vomiting
|
|
Intervention(s)
|
|
Drug: Ginger
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Nausea score
[Time Frame: The first 5 days of chemotherapy cycle]
|
|
Secondary ID(s)
|
|
732/2557(EC1)
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|