Status:
COMPLETED
Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy
Lead Sponsor:
Helsinn Healthcare SA
Conditions:
Cancer
Nausea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is verify the capability of a standardized Ginger (Zingiber officinale) extract to manage nausea in cancer patients receiving highly emetogenic treatments and standard anti-em...
Detailed Description
This study is a randomized, double-blind, placebo controlled, multicenter study with two parallel groups of patients. The study will be conducted in 5 Italian clinical sites and will involve 250 pati...
Eligibility Criteria
Inclusion
- Male and Females aged \> 18 years.
- Naïve to chemotherapy.
- Patients planned to receive at least 2 cycles of highly emetogenic treatments with cisplatin in single dose \> 50 mg/m2 every 21 or 28 days.
- Willing and able to understand and sign informed consent and complete the patient diary.
Exclusion
- Presence of brain symptomatic metastases (in case of small, asymptomatic metastases and in absence of steroids treatment, the patient is eligible).
- Scheduled to receive or having received in the past 4 weeks radiation treatment to brain, abdomen or pelvis.
- Emesis or significant nausea within 24 hours before first chemotherapy cycle.
- Known hypersensitivity reaction to Ginger or any components of the product.
- Patients with coagulopathies causing potential increase risk of bleeding.
- Patients on therapy with oral anticoagulants.
- Planned surgery procedures in the period of the study or within 2 weeks after the study conclusion.
- History of seizures.
- Active use of cannabinoids.
- Known current or past drug or alcohol abuse.
- Use of other investigational drugs within 30 days before study entry or during the study.
- Clinically significant findings on physical exam or presence of known clinically significant disease that would interfere with study evaluation
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01887314
Start Date
June 1 2013
End Date
October 1 2015
Last Update
January 27 2016
Active Locations (6)
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1
Istituto Nazionale dei Tumori
Milan, Italy, 20133
2
IEO -Istituto Europeo di Oncologia-
Milan, Italy, 20141
3
Ospedale S. Gerardo
Monza, Italy, 20052
4
Policlinico Umberto I
Rome, Italy, 00186