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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Helsinn Healthcare SA
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT01887314
First received: June 24, 2013
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Cancer
Nausea
Vomiting
Dietary Supplement: Standardized Ginger extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Protection from delayed vomiting (number of emetic episodes in delayed phase) [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]
  • Use of antiemetic rescue medication. [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]
  • Overall fatigue assessment (BFI questionnaire) [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Biochemical markers [ Time Frame: Two High Emetogenic chemotherapy cylces (41 or 55 days) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: Yes ]
    Number and typology of adverse events


Estimated Enrollment: 250
Study Start Date: June 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CINVQOL
  • ZINGIQOL
Placebo Comparator: Placebo soft gel capsules
Patients receive 2 soft gel capsules of Placebo, twice a day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887314

Contacts
Contact: Paolo Bossi, M.D. paolo.bossi@istitutotumori.mi.it

Locations
Italy
Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Paolo Bossi, MD       paolo.bossi@istitutotumori.mi.it   
Principal Investigator: Paolo Bossi, M.D.         
IEO -Istituto Europeo di Oncologia- Recruiting
Milan, Italy, 20141
Contact: Franco Nolè, MD         
Principal Investigator: Franco Nolè, MD         
Ospedale S. Gerardo Recruiting
Monza, Italy, 20052
Contact: Diego Cortinovis, MD         
Principal Investigator: Diego Cortinovis, MD         
Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori "Regina Elena" Recruiting
Rome, Italy
Contact: Alessandra Fabi, MD       fabi@ifo.it   
Principal Investigator: Alessandra Fabi, MD         
Policlinico Umberto I Recruiting
Rome, Italy, 00186
Contact: Patrizia Seminara, MD         
Principal Investigator: Patrizia Seminara, MD         
Ospedale S. Maria Recruiting
Terni, Italy, 05100
Contact: Fausto Roila, MD         
Principal Investigator: Fausto Roila, MD         
Sponsors and Collaborators
Helsinn Healthcare SA
Investigators
Principal Investigator: Paolo Bossi, M.D. Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  More Information

No publications provided

Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01887314     History of Changes
Other Study ID Numbers: HF01-12-69, HF01-12-69
Study First Received: June 24, 2013
Last Updated: February 12, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Helsinn Healthcare SA:
Nausea
Cancer
Cisplatin
Ginger
Zingiber officinale
5HT3
Dexamethasone
Neurokinin-1 (NK-1)
Interleukin-6 (IL-6)
Tumor necrosis factor-alpha (TNF-alpha)
Insulin like growth factor-1 (IGF-1)
Placebo
FLIE
BFI

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Emetics
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 26, 2014