CancerNCT01887314
Efficacy Study of Ginger (Zingiber Officinale) Extract "Ginpax" to Manage Nausea in Cancer Patients Receiving High Emetogenic Treatments and Standard Anti-emetogenic Therapy
A study testing Standardized Ginger extract in people with Cancer and Nausea, run by Helsinn Healthcare SA at 6 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Standardized Ginger extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 6 sitesItaly
- Study dates
- Jun 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Istituto Nazionale dei Tumori
Milan, 20133
IEO -Istituto Europeo di Oncologia-
Milan, 20141
Ospedale S. Gerardo
Monza, 20052
Policlinico Umberto I
Rome, 00186
Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori "Regina Elena"
Rome
Ospedale S. Maria
Terni, 05100
About this study
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.
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.
Read the 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.
- Being tested
- Standardized Ginger extract
- Keywords
- Cancer, Cisplatin, Nausea, 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
- Medical subject headings
- Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Ginger extractDietary supplement
Also called Ginpax
| Study group | Role | What they receive |
|---|---|---|
| Standardized Ginger extract soft gel capsules | Experimental | Patients receive 2 soft gel capsules of Ginger extract, twice a day Receives: Dietary Supplement: Standardized Ginger extract |
| Placebo soft gel capsules | Placebo comparator | Patients receive 2 soft gel capsules of Placebo, twice a day Receives: Dietary Supplement: Standardized Ginger extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Ginger in protecting patients from delayed nausea (incidence of no delayed nausea and non-significant delayed nausea)
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.
Measured: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Secondary outcomes (3)
Protection from delayed vomiting (number of emetic episodes in delayed phase)
Measured: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Use of antiemetic rescue medication.
Measured: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Overall fatigue assessment (BFI questionnaire)
Measured: Two High Emetogenic chemotherapy cylces (41 or 55 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Bossi, M.D., Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887314
- Sponsor's protocol ID
- HF01-12-69
- Other IDs
- HF01-12-69
- Status last verified
- Jan 2016
- First submitted
- 24 Jun 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01887314
- Acronym / sponsor ID
- HF01-12-69
- Keywords
- Cancer, Cisplatin, Nausea, Ginger, Zingiber officinale, 5HT3, Dexamethasone, Neurokinin-1 (NK-1)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Ginger extract soft gel capsules | Experimental | Dietary Supplement: Standardized Ginger extractPatients receive 2 soft gel capsules of Ginger extract, twice a day |
| Placebo soft gel capsules | Placebo comparator | Dietary Supplement: Standardized Ginger extractPatients receive 2 soft gel capsules of Placebo, twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Ginger extractAlso: Ginpax | Dietary supplement | Placebo soft gel capsules, Standardized Ginger extract soft gel capsules |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bossi, M.D. principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Ginger extract in people with Cancer and Nausea, run by Helsinn Healthcare SA at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.