NCT01887314

Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy

Multicenter, Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Activity of a Ginger (Zingiber Officinale) Food Supplement in the Management of Nausea in Patients Receiving Highly Emetogenic Treatments and Standard Anti-emetogenic Therapy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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-emetogenic therapy.

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 patients receiving at least 2 cycles of highly emetogenic treatments. Patients will be randomly assigned to Ginger treatment or to its Placebo. All patients will receive, at each chemotherapy cycle, the standard 5-HT3 receptor antagonist antiemetics plus dexamethasone and NK1 receptor antagonist. This will guarantee to all patients an antiemetic prophylaxis for acute and delayed nausea. No additional treatment is usually foreseen for nausea and this justifies the use of placebo in the control group. Patients will start the study treatment on the day after chemotherapy cycle and will continue until the day of the following cycle; they will suspend the study treatment on the chemotherapy day and will start again on the next day. The choice not to treat the patients with the study product on the chemotherapy day is intended to avoid any possible interference with antiemetic therapy of the first day and chemotherapy, and to analyze the impact of Ginger in delayed phase without confounding factors in acute phase. Main efficacy assessment of this study is: \- To evaluate the protection from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea); Other efficacy assessments regarding nausea that will be evaluated are: * To evaluate the severity of delayed nausea; * To evaluate the overall duration of nausea; * To evaluate inter cycle nausea; * To evaluate nausea anticipatory symptoms before the 2nd cycle. Secondary efficacy assessments of this study are: * To evaluate protection from delayed vomiting (number of emetic episodes in delayed phase); * To evaluate the impact of nausea/vomiting on daily life activities (FLIE30 questionnaire); * To evaluate the use of antiemetic rescue medication; * To evaluate the compliance to the treatment; * To assess overall fatigue (BFI31 questionnaire). Safety assessments of this study are: \- Number and typology of adverse events.

Conditions

• Cancer
• Nausea
• Vomiting

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standardized Ginger extract

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2013-06-26
• Last updated: 2016-01-27

Locations

6 sites across 1 country: Italy