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

January 26, 2016 updated by: Helsinn Healthcare SA

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Istituto Nazionale dei Tumori
      • Milan, Italy, 20141
        • IEO -Istituto Europeo di Oncologia-
      • Monza, Italy, 20052
        • Ospedale S. Gerardo
      • Rome, Italy, 00186
        • Policlinico Umberto I
      • Rome, Italy
        • Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori "Regina Elena"
      • Terni, Italy, 05100
        • Ospedale S. Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standardized Ginger extract soft gel capsules
Patients receive 2 soft gel capsules of Ginger extract, twice a day
Dietary supplement: Standardized Ginger extract
Other Names:
  • Ginpax
Placebo Comparator: Placebo soft gel capsules
Patients receive 2 soft gel capsules of Placebo, twice a day
Dietary supplement: Standardized Ginger extract
Other Names:
  • Ginpax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea)
Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days)

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.
Two High Emetogenic chemotherapy cylces (41 or 55 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Protection from delayed vomiting (number of emetic episodes in delayed phase)
Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Two High Emetogenic chemotherapy cylces (41 or 55 days)
Use of antiemetic rescue medication.
Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Two High Emetogenic chemotherapy cylces (41 or 55 days)
Overall fatigue assessment (BFI questionnaire)
Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Two High Emetogenic chemotherapy cylces (41 or 55 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical markers
Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days)

On a restricted number of patients enrolled at the coordinating center, additional blood samples will be collected for IL-6, TNF-alpha, IGF-1 evaluation.

The purpose of this additional research is to evaluate if the consumption of ginger can affect serum concentration of such factors.
Two High Emetogenic chemotherapy cylces (41 or 55 days)
To evaluate the safety profile of the product containing Ginger extract.
Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Number and typology of adverse events
Two High Emetogenic chemotherapy cylces (41 or 55 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinn Healthcare SA

Investigators

  • Principal Investigator: Paolo Bossi, M.D., Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HF01-12-69 (Other Identifier: Helsinn Healthcare SA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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