Cancer | Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy
Cancer research study
What is the primary objective of this study?
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-emetogenic therapy.
Who is eligible to participate?
Inclusion Criteria: - 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 Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Standardized Ginger extract
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Standardized Ginger extract soft gel capsulesPatients receive 2 soft gel capsules of Ginger extract, twice a day
Placebo soft gel capsulesPatients receive 2 soft gel capsules of Placebo, twice a day
Start Date: June 2013
Completed Date: October 2015
Primary Outcome: To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea)
Secondary Outcome: Protection from delayed vomiting (number of emetic episodes in delayed phase)
Study sponsors, principal investigator, and references
Principal Investigator: Paolo Bossi, M.D.
Lead Sponsor: Helsinn Healthcare SA