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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01887314
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA

Tracking Information
First Submitted Date  ICMJE June 24, 2013
First Posted Date  ICMJE June 26, 2013
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
  • Protection from delayed vomiting (number of emetic episodes in delayed phase) [ Time Frame: 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) ]
  • Overall fatigue assessment (BFI questionnaire) [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2013)
  • 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.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Nausea
  • Vomiting
Intervention  ICMJE Dietary Supplement: Standardized Ginger extract
Other Name: Ginpax
Study Arms  ICMJE
  • Experimental: Standardized Ginger extract soft gel capsules
    Patients receive 2 soft gel capsules of Ginger extract, twice a day
    Intervention: Dietary Supplement: Standardized Ginger extract
  • Placebo Comparator: Placebo soft gel capsules
    Patients receive 2 soft gel capsules of Placebo, twice a day
    Intervention: Dietary Supplement: Standardized Ginger extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2013)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01887314
Other Study ID Numbers  ICMJE HF01-12-69
HF01-12-69 ( Other Identifier: Helsinn Healthcare SA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helsinn Healthcare SA
Study Sponsor  ICMJE Helsinn Healthcare SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paolo Bossi, M.D. Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
PRS Account Helsinn Healthcare SA
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP