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IGF-1

Insulin-like Growth Factor 1, Somatomedin C

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Studies 92
Trials 100
Completed NA INTERVENTIONAL NCT01887314

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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-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.

Interventions

Name: Standardized Ginger extract
Type: DIETARY_SUPPLEMENT
Description:

Primary Outcomes

Measure: To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea)
TimeFrame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Description: The level of nausea will be assessed through a Visual Analogue Scale (VAS 0-100 mm) included in the patients' daily diary. The patients will be asked to report the maximum level of nausea experienced during each day. During each chemotherapy cycle, the nausea occurring between day 2 and day 5 will be defined as "delayed nausea", the nausea occurring between day 6 and day 19/26 will be considered as "inter-cycle nausea". The day before the next chemotherapy cycle (day 20/27), "anticipatory nausea" symptoms will be collected.

Trial Information

NCT ID

NCT01887314

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Helsinn Healthcare SA

Last Updated

December 15, 2025